MAUDE Adverse Event Reporting--Cosmetic Devices

MAUDE - Manufacturer and User Facility Device Experience. MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Also, warning letters issued to device makers for FDA violations.

Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 6:33 pm

THERMAGE THERMACOOL LASER THERMAGE AND CUTERA
Event Date 08/08/2003
Event Type Injury Patient Outcome Required Intervention;
Event Description
A little over 5 years ago, i did thermage. I didn't notice any damage immediately, but i felt like i was aging much faster than before, with noticeable changes almost daily. I complained to the laser doc that i wasted my money and i even went back for an "after" picture and noticed it looked like i had lost weight - i hadn't yet made the connection since i'd never heard of the fat loss thing. The doctor denied anything happened and told me i must have had some metabolic problem. A few years later, i was getting frustrated with my rosacea and rapid aging and went for 2 back-to-back ipl treatments -with a highly recommended derm i researched-. I noticed immediately that something had gone horribly wrong. My rosacea flared up, i had burning and twitching all over my face -even felt like fat cells popping!-, my texture quickly got even worse then before with huge pores, sandblasted/orange-peel texture, very thin/crepey/krinkly/fragile dry skin, some weird bumps, and no elasticity - i could pull thin parts and it wouldn't bounce back right away. I would wake up with pillow marks and they wouldn't go away until lunchtime. My cheeks disappeared, everything sagged and got loose, i got indents in my chin and jiggly chicken neck, jowles, my eye sockets hollowed and lids drooped, even my temples through my hairline got mushy. The loss of fat around my eyeballs depressurized the sockets and the eyeballs dropped way back into my head. I look gaunt and sick and i'm even afraid to workout for fear of losing more precious fat on my face! again, the doctor denied any problem. No lawyer showed interest in a case. And i don't necessarily feel better as long as i don't look into a mirror, because i feel droopy and dread touching my face to itch it or wash it because it feels hollow, loose and bony rather then padded like before -i'm afraid to let anyone touch my face and i used to love having someone caress my face-. Lying against the pillow, i feel pressure points on my cheekbones and brow bones and the veins in my temples twitch like they're being constricted. I even feel like the disappearance of fat impacted my hair follicles, because my brows, lashes and scalp hair are falling out and are getting unbearably fine and dry. This whole thing has sent me into a deep depression especially since being single -i even had to miss a month of work to get help-. I mourn my skin every second of every day, even when i'm asleep -when i actually can sleep-. I now have social anxiety and so little confidence i can't excel at work. I avoid even running simple errands. I heard that fat grafts are very expensive, risky and may not even last. The laser damage has ruined my entire life and future. Dose or amount: #1 1 treatment, #2 2 treatments. Diagnosis or reason for use: aging, rosacea. Event abated after use stopped or dose reduced?: no.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 6:36 pm

LUMENIS, INC.
Event Type Injury
Event Description
A pt filed a maude event report, reporting they sustained shallow indentations, possible fat loss, holes, skin texture changes, lines and other marks all over their face. It is unk if the pt required medical intervention. No user facility or device info was provided.


Manufacturer Narrative
Reasonable attempts were made to obtain further info from pt regarding adverse event and user facility info. No add'l event or user facility info was made available. Should add'l info be obtained, a f/u mdr will be filed.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 6:37 pm

GEMINI -532/1064 PDL -595- PULSED DYE LASER
Event Date 09/25/2006
Event Type Injury Patient Outcome Required Intervention;
Event Description
In 2006, dr. Of skincare physicians was treating my rosacea with the pulsed dye laser for the second time when something happened- it was very painful- and the laser burned my skin and left me with permanent side effects. I have small scars all over my face- textural changes-, nerve damage, fat loss - the most upsetting-, and loss of elasticity. I have textural changes inside and outside my skin. My facial structure changed because of the fat loss. The dermatologist denied the whole thing and would not lift a finger to help me. He ran away and abandoned me to cope with this on my own. This led me to seek help from other dermatologist who did not know me, never saw me before and looked at me as a liability case. Every time i would mention the word laser to the dermatologist, i came to see for help, it seemed like a door would shut in my face. Throughout this dilemma only one doctor helped me and treated me and i thank god for her. I had no before and after photos since skincare physicians does not feel they need to take them. The nurse at skincare said that they are not required to do so. I was also told they are not required to give before and after procedure instructions. This was told to me after my side effects from the laser. The place is supposed to be a reputable dermatology office, yet when something happened, i was shunned by the doctor even though he is aware and knows that i have the side effects. I trusted him completely and never in my life thought that i would have to go through this horrible pain and abuse. When i told him that the laser burned my skin and scarred it, he replied that "lasers don't burn, lasers don't scar, and scars are big. " i know now that prior to this laser treatment, even though i had rosacea, i had good and lovely skin. If i knew what i know now i would run from skincare physicians and never have had the laser touch my skin. These side effects are not recorded, so a lot of people are not aware of them. I had to research on my own to find out what happened to me and i found that i was not the only one. I learned what the laser is what it can do. Laser beams are capable of causing a localized vaporization of tissue which in turn can create a mechanical shockwave to be propagated through the tissue -acoustic effects-. Shockwaves can cause tearing of the tissue. Laser light can also cause changes to tissue -photochemical effects-. There are other people suffering from the same side effects. These side effects are devastating and cause a lot of pain, depression, stress, and anxiety. Lasers can be unpredictable even in an experienced doctor's hands, because they can make mistakes. I am writing this complaint to make the u. S food and drug administration aware of the damage these devices can cause, in particular "fat loss" which is a devastating deformity and is very expensive to fix for a lot of people like me. My first treatment had a lower setting and it went ok. I was told i needed 3 treatments.


Event Description
This is an addendum to previous report for an adverse event reported on 11/25/2008; in 2006 a dermatologist burned, scarred, and damaged my face while treating my rosacea with the gemini laser. This description should be included under the brand name.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 6:38 pm

STARLUX IPL MACHINE PALOMAR STARLUX IPL MACHINE
Model Number PALOMAR STARLUX IPL
Event Date 09/17/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
I have been physically and emotionally very damaged by the palomar starlux intense pulsed light machine, put on a very low setting. I had a few pesky red veins on my cheek and nose. They bothered me a bit, but when my boyfriend pointed them out, i decided i would get them zapped. I researched and researched to make sure i found the top laser doc, as i knew it would be dangerous to let someone under-trained loose on my face with a laser. I found a top dr. He had many positive reviews all over the internet, had been interviewed on tv and in the press as an expert. I made an appointment to see him. He was very reassuring. We did ipl with a palomar starlux machine on a very low setting. Wow! the veins vanished and my skin was so creamy! i loved it! he recommended five sessions in a row, 6 weeks apart. I thought that was a little excessive, so i waited a whole year before i went back for another treat of ipl. I deserved for working so hard! during that period, all the veins returned. My face also became more sensitive than before, and got red a lot. I assumed it was mild rosacea developing. Dr agreed. He zapped me again! again, i looked fabulous until 6 months later when i kept getting red again. I also noticed what i thought was a very very mild scarring on my cheek, but i believed it couldn't have been the ipl. The dr was an expert and the settings were so low. So off for my third and final ipl session. Dr kindly said "shall we turn the heat up?". I said "ok", after all he was the expert! again, i left looking truly fabulous as always. "you look gorgeous, you look well, your skin looks brilliant", said all my friends. I looked hot and i knew it! thank ipl! fast forward 4 weeks. I noticed some red blotches on my cheek that weren't there before. Also, a small hole presented itself on my right cheek. My skin felt "creepy" and looked "creepy". I was also having severe burning attacks on my face. They hurt. I looked somehow older. I did a bit of research on the net and saw a few posts on facial fat loss from ipl. I got scared and went back to the dr. He was very dismissive. I was imagining it. Fair enough, i thought, maybe i was. As the days passed, my face changed daily. The worst occurred in the 2 to 3 month period. The small hole in my cheek spread, half of my right cheek looked like it had been burnt and sunken. Like it had been scorched. My whole face generally deflated, and shrunk like a grape turning into a raisin. Small scars appeared across my cheeks, like little cuts. The burning continued. My face got red and blotchy. I had more veins than i did before the ipl, plus the old ones came back. I was in pieces. I went back to the dr. Again, he was very dismissive. There was nothing there, it was all in my head. This couldn't possibly have ever happened as he had done hundreds of ipls and never seen it. The settings were so low, and besides, ipl cannot cause facial fat loss as it doesn't penetrate deep enough, he said. The thinning of my face continued for months. Now, i look gaunt, pale, my skin is covered in small scars, is sunken and blotchy. I look so much older. Sometimes i hardly recognize myself in the mirror. I look ill. I have lost my once very beautiful face. I lost my confidence. I became very depressed. I used to love doing myself up and going out. Now i find it hard to look in the mirror. I just want my old face back, but am scared to try and fix it in case i make things worse. I had no idea that this could have ever happened to me. If i had, i would run very far in the opposite direction. It has devastated me emotionally and physically. I became depressed and reclusive and my life has been destroyed. I know of many other women who have experience devastating facial fat loss with ipl, and specifically with palomar starlux. One woman wrote to palomar to tell them what happened and they sent her a letter back threatening her with legal action, when it was them that had totally destroyed her face. Nowhere on the consent form did it say that facial fat loss was a risk. The dr said the settings were very low that no damage could possibly have happened which leads me to believe this is a very dangerous machine that should be taken off the market. Belinda. Dose or amount: low setting - i think 32-. Event abated after use stopped? no. Diagnosis or reason for use: rosacea.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 6:40 pm

CORPORATION VBEAM PERFECTA DERMATOLOGY LASER
Model Number 9914-08-0300
Event Date 10/21/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Medwatch report was received on september 8, 2008. A pt submitted an adverse event to fda reporting that she had five treatments with the vbeam perfecta for hyperpigmentation, "skin rejuvenation", and broken capillaries. The pt stated that a board certified plastic surgeon had confirmed that she suffered several burns that permanently scarred her face. She also stated that the scars continue to appear. The pt had been prescribed retin-a throughout the treatment because of her concerns regarding wrinkling on the face. Use of retin-a was stopped 2 days before each treatment and was resumed approx one week after each treatment.


Manufacturer Narrative
Without info regarding the location where the pt received treatment, candela cannot perform an eval of the device. The complaint database has been reviewed, and a specific complaint associated with this particular event or a similar event describing the type of injury reported by the pt has not been identified. It is advised within the treatment parameters that the use of topical anesthetics cease 72 hours before treatment. Based on the info provided, the pt stopped using retin-a two days (48 hours) prior to treatment. The use of a topical medication within 72 hours may have been a contributing factor to the injury.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 6:42 pm

RELIANT TECHNOLOGIES FRAXEL REPAIR LASER
Model Number FRAXEL III LASER SR
Event Date 05/09/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
A doctor used the fraxel repair laser by reliant technologies. It was supposed to be a 3-5 day healing time. A week later my face was still swollen and bright red with strange lines running through the skin. A month later, i was still wearing wet bandages and not able to leave the house. The wet bandages were to avoid scars, my doctor said. My skin was raised with white scar looking lines, which were biopsied and came back inconclusive. The white growth on my face partially subsided in about 3 months, but i was left with about 4 small scars, hypo pigmentation, really rough skin, laser lines, and hyper pigmentation. I spoke to the fda liasion at fraxel and the vp of sales, because even after they were aware of my situation, their sales rep was still stating that there is no scarring caused by this laser. They also state in their ads that there is no risk like a traditional co2 laser. Obviously, since my healing is still going on at 4 months, i have scars, i have hypo pigmentation, this is not true. We, the consumer need accurate and accountable marketing processes. Please help. Fraxel repair laser. Treatment date : the same day. Wore wet bandages for a month. Until the skin is healed no treatments can be performed. Doctors are hoping skin can get to 90% better with a treatment of 8 laser treatments over the next year. Hypo pigmentation may or may not be permanent, only time will tell.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 6:43 pm

CANDELA V BEAM LASER CANDELA PERFECTA
Model Number 595 PERFECTA
Event Date 04/10/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
Had candela vbeam preformed by a dr. After procedure, i suffered immense swelling on right side of face. It has been 3 months and i still have serious residual swelling with edema. I went to dr for skin reguvenation. She said vbeam would be her choice. I have since gone back to her, and she gave me antihistamines and told me this should resolve. I have gone to another dr and what i have is scarring dermal and edema. I am very worried this is permanent as i am seeking another opinion. Dates of use: 2008. Diagnosis or reason for use: skin reguvenation.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 6:44 pm

PALOMAR MEDICAL TECHNOLOGIES PALOMAR STARLUX SYSTEM LUXIR FRACTIONAL HANDPIECE
Event Date 02/24/2007
Event Type Injury Patient Outcome Disability;
Event Description
This is in regards to a cosmetic device for skin tightening. The palomar starlux system with luxir fractional infrared handpiece for laser skin tightening. I noticed after first treatment on the face and neck that skin was getting looser and circles and puffiness under eyes. The doctor said i needed to be patient because it would take time to improve. I had 4 treatments and a year later, i am still having tingling, burning, stiffness and more loose skin than i started with. My right eye and right ear twitches. He did the side of and front of my neck and face. I also had microdermabrasion and photo facial. I have written 3 letters to palomar to find out more about laser tightening and if there are any ill effects and they have not responded. I would not recommend this skin tightening procedure to anyone. My family and friends saw me get worse after the first 2 treatments. I'm sorry i ever had this done. I know i am approaching 60 but no one ages and see so many changes in a two month period. My family wanted me to stop treatments but i believed the doctor when he said, it would take time and more treatments to see improvement. I just want to make sure this procedure is safe for use. It has affected my life terribly and i wouldn't want to see someone else go through this. Thank you. Dates of use: 2007. 4 months. Diagnosis or reason for use: skin tightening.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 6:45 pm

PALOMAR PALOMAR STARLUX IPL, PHOTOFACIAL
Model Number NOT SURE
Event Date 03/04/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
Had 1 ipl treatment done to my face at medspa, using the palomar starlux. Not sure what the settings were because when i asked a month later, i was told that was something shared between estheticians. They didn't even use goggles, just a piece of gauze over my eyes. The entire time the esthetician hurriedly zapped my face while she was trying to trying to sell me a series of laser hair removal. One week after treatment, i noticed small brown depressed scars under my eyes - one of the scars was where i had a small freckle, the other two i had no freckles there to begin with - and my skin was extremely dry. One and a half weeks after treatment i had 2 areas of small bumps on my forehead that looked crinkly. At 1st i thought this was part of the process and my skin would flake and heal itself. Four weeks after treatment, i went to the medspa to ask what happened to my forehead and to report strange sensations on the sides of my face that were almost numbing. I met with the head esthetician and was told that my damage was superficial, that she did not believe ipl could have caused it and that my series of treatments - 10 mild chem peels and 6 ipls - were nonrefundable even though i did not inquire about a refund. There was an air of attitude that i somehow caused this damage myself and was chided for not saying anything to my esthetician at my light chem peel 2 weeks after the ipl. I didn't say anything about the bumps or brown spots at my chem peel because i seriously thought that the changes were part of the process. She even said i could've had a reaction to the chem peel, but that is not true as i had a series of the same peels done in another state 5 years ago with great results and no adverse effects. I only wanted to find out what happened to my face and how to correct it. I was told that micro derms and peels could help or even more ipl, but i have not been back since for any additional treatments and am still paying for the treatments because i signed a contract. She also told me that the strange sensations must be hormonal or from seasonal changes - but that has never happened to me before - at 5 weeks after treatment, i started getting a shiny film on my face that would not come off, my skin quit sweating, and i started getting wrinkles under my eyes that extend down my cheeks to around my mouth when i smile. The wrinkles are so noticeable that a coworker mentioned it. I did not even ask her about my skin so it was an unprovoked comment. Even my husband can see the changes happening now. It has just kept getting worse and the skin on my left temple just looks so shiny and scaly that it does not even resemble skin. My skin is less firm and the quality of it gets worse by the week. I am scared that it will just keep getting worse and that i will never be able to get my old skin back. Dose or amount: sleek medspa would not tell me. Dates of use: 15 minutes; 2008. Diagnosis or reason for use: broken capillaries. Event abated after use stopped: no.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 7:04 pm

ERCHONIA (ERCHMEDIC) 635 NANOMETER LIGHT (NHN)
Event Date 04/28/2010
Event Type Injury Patient Outcome Other;
Event Description
Patient had light therapy on face for trigeminal neuralgia. Treatment caused nausea, sweats, shaking, patient unable to drive and almost passing out. Patient has had four episodes since treatment. Now seeing neurologist and cardiologist for cause. Patient would like to know if goggles should have been worn during treatment.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 8:39 pm

CANDELA CORP. GENTLE YAG DERMATOLOGY LASER
Model Number 9914-00-0950
Event Date 08/16/2005
Event Type Injury Patient Outcome Other;
Event Description
During inservice laser training by candela, a customer staff member had facial telangectasia treated. The employee incurred permanent scarring / indentations in the area treated.

Manufacturer Narrative
Believe higher fluence was selected for procedure than guidelines recommend. This may have occurred from making an error in reading the guidelines.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 8:44 pm

Anyone here who had VBeam warned of this (since 2005)?

CANDELA CORP. VBEAM DERMATOLOGY LASER
Model Number 9914-00-0720
Event Date 05/03/2004
Event Type Injury Patient Outcome Other;
Event Description
Pt received treatment for spider veins on upper and lower legs with a vbeam laser. Over the shins and ankles the pt developed a blue-green pigmentation at all treatment sites. The pigment change is still present after one year. The upper legs were not effected. Pt was on estratest - 1. 25mg and estring - 2 mg.


Manufacturer Narrative
This is the first report of this adverse effect. Labeling will be updated to include possible color and texture pigmentation changes. The cause in this case is unk. Future occurrances will be monitored.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 8:49 pm

THERMACOOL/THERMAGE DERMAL LASER MACHINE
Event Date 12/17/2003
Event Type Injury Patient Outcome Required Intervention; Other
Event Description
Pt had facial cosmetic skin laser procedure. Since that time, pt has suffered from substantial "ue" to facial fat loss, particularly under eye area and cheek. Pt did lots of online research prior to this procedure and did not see anything related to this side effect - was not informed by the dr or saw any documentation presented by the product co that this was a potential side effect. In speaking w/their reps, they claim only 6 out of 50k cases had problems of this nature, which is bunk, because pt personally knows of at least 6 people in the last few months that have contacted them. These cases include severe scarring, dents and dimples related to this procedure. Also at the time of procedure in 2003, fda approval was only for certain areas of the face, including under eye, cheek, but drs were being instructed by the co to treat entire faces. Thermage is denying damage due to their product and appears to be using stall tactics -probably so state statute of limitations will run out before resolution- among other things to deal with complaints. As of their latest brochures they are now touting this facial fat loss as a benefit and calling it 'contouring'. Outrageous. All of thermage damage victims are having to look at expensive corrective medical procedures to correct this. Some of them irrevocably physically and emotionally devastated by the results of this errant procedure. Please look into removing this dangerous product from the market.
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 8:51 pm

CANDELA CORP. VBEAM DERMATOLOGY LASER
Model Number 9914-00-0720
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
Immediatge blistering was noted after two laser pulses were delivered. The procedure was stopped. Cause of problem, selection of treatment parameter or a product related problem. Cause is undetermined.

Event Description
Distributor reported that a pt received two laser pulses on upper lip that resulted in a hypertrropic scar

Brand Name VBEAM
Type of Device DERMATOLOGY LASER
Baseline Brand Name VBEAM LASER
Baseline Generic Name DERMATOLOGY LASER
Baseline Catalogue Number 9914-00-0720
Baseline Model Number 9914-00-0720
Manufacturer (Section F) CANDELA CORP.
530 boston post rd.
wayland MA 01778

Manufacturer (Section D) CANDELA CORP.
530 boston post rd.
wayland MA 01778

Manufacturer Contact ed gramer
530 boston post rd
wayland , MA 01778
(508) 358 -7637

Device Event Key 525851
MDR Report Key 536602
Event Key 509457
Report Number 1218402-2003-00071
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/27/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 07/27/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number 9914-00-0720
Device Catalogue Number 9914-00-0720
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received 11/30/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured 10/01/2001
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
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Re: MAUDE Adverse Reaction Filings--100's & 100s

PostPosted by DCNGA » Wed Aug 11, 2010 9:00 pm

CANDELA CORP. VP YAG LASER SYSTEM DERMATOLOGY LASER Model Number 9914-00-0950
Event Date 09/23/2005
Event Type Injury Patient Outcome Disability;
Event Description
Over a period of time, five pt's received adverse events following facial laser telegietasia treatment using a 3mm spot size delivery system. Parameter settings were 240 j/cm2 40ms with dcd setting of 15/20/10 ms. Five individual medwatchers are being submitted associated with each individual pt. In this case, the pt had pustules within 24 hrs and left depressions on facial area along the nose/face crease possible scar.

Brand Name VP YAG LASER SYSTEM
Type of Device DERMATOLOGY LASER
Baseline Brand Name GENTLE YAG (METALIC GRAY) WITH DCD
Baseline Generic Name DERMATOLOGY LASER
Baseline Catalogue Number NA
Baseline Model Number 9914-00-0950
Baseline Device Family LONG PULSE ND: YAG
Baseline Device 510(K) Number K033172
Is Baseline PMA Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months) NA
Date First Marketed 03/26/2004
Manufacturer (Section F) CANDELA CORP.
530 boston post road
wayland MA 01778

Manufacturer (Section D) CANDELA CORP.
530 boston post road
wayland MA 01778

Manufacturer Contact ed gramer
530 boston post road
wayland , MA 01778
(508) 358 -7400

Device Event Key 682538
MDR Report Key 693410
Event Key 659855
Report Number 1218402-2006-00031
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/27/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 03/28/2006
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number 9914-00-0950
Device Catalogue Number 9914-00-0950
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Was Device Evaluated By Manufacturer? No
Date Device Manufactured 06/01/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
"It is a good thing to learn caution from the misfortunes of others."

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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Oct 11, 2010 9:11 am

This patient was deemed to have 'psychological' problems and was being sent for a 'psyche' eval. Poor woman:

Lumenis LightSheer
Event Date 01/01/2007
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
An eval of the reported event details including a conversation between a lumenis medical subject matter expert and the pt's primary care physician, (b)(6), concluded that the subject device was not related to the pt's reported condition. The primary care physician reported that they were working on the mental health aspect of the pt's sequela.

Event Description
It was reported by the pt that they sustained redness, a burning sensation, and tightness of the throat six months post hair removal treatment to the face with a lumenis lightsheer laser. The pt refused to report user facility info.



Search Alerts/Recalls

Brand Name LIGHTSHEER
Type of Device DIODE
Manufacturer (Section F) RH USA, INC.
201 lindbergh ave
livermore CA 94551

Manufacturer (Section D) RH USA, INC.
201 lindbergh ave
livermore CA 94551

Manufacturer Contact steve kachocki
5302 betsy ross dr,
santa clara , CA 95054
(877) 586 -3647

Device Event Key 1881875
MDR Report Key 1845392
Event Key 1745816
Report Number 2914019-2010-00043
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 09/15/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 09/15/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 09/14/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/15/2010 Patient Sequence Number: 1

"It is a good thing to learn caution from the misfortunes of others."

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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Oct 11, 2010 9:16 am

Lumenis Ultrapulse:

LUMENIS LTD. YOKNEAM ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASER Back to Search Results

Model Number GA-0000440
Event Date 08/05/2010
Event Type Injury Patient Outcome Other;
Event Description
It was reported that a pt sustained burns and post-procedure infection following treatment using an ultrapulse laser. It was further reported the pt was administered antibiotic, antifungal, and antiviral medication as medical intervention.


Manufacturer Narrative
No device malfunction was reported or observed therefore, no eval of the subject device by lumenis technical specialist was performed. A review of service records showed that the subject device had been serviced on (b)(6)2010. Reasonable attempts by e-mail were made to obtain additional info from the user facility including specific treatment parameters, however, only pt photos were provided. A review of device labeling confirmed that post treatment infection is a potential complication of laser resurfacing treatment. A review of the event details by a lumenis medical subject matter expert concluded the probable root cause to be excessive treatment parameters and/or inadequate antibiotic, antiviral, and/or anti-yeast treatment either pre- or post-treatment.

Brand Name ULTRAPULSE ENCORE
Type of Device CARBON DIOXIDE SURGICAL LASER
Manufacturer (Section F) LUMENIS LTD. YOKNEAM
13 hayetzira st
yokneam industrial park
yokneam

Manufacturer (Section D) LUMENIS LTD. YOKNEAM
13 hayetzira st
yokneam industrial park
yokneam

Manufacturer (Section G) LUMENIS LTD. YOKNEAM
13 hayetzira st
yokneam industrial park
yokneam

Manufacturer Contact annie hung
5302 betsy ross rd,
santa clara , CA 95054
(877) 586 -3647

Device Event Key 1881924
MDR Report Key 1845410
Event Key 1745832
Report Number 2914019-2010-00041
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 09/15/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 09/15/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number GA-0000440
Device Catalogue Number GA-0000440
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 08/16/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured 12/01/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/15/2010 Patient Sequence Number: 1


"It is a good thing to learn caution from the misfortunes of others."

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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Oct 11, 2010 9:18 am

Lumenis ndYag device:

LUMENIS LTD. YOKNEAM LUMENIS ONE ND:YAG SURGICAL LASER DELIVERY DEVICE Back to Search Results

Model Number IPL
Event Date 08/17/2010
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
An eval of the reported event details by a lumenis medical subject matter expert and a review of the dfu concluded the probable root cause to be overlap of pulses on the treatment site in contraindication to dfu.


Brand Name LUMENIS ONE
Type of Device ND:YAG SURGICAL LASER DELIVERY DEVICE
Manufacturer (Section F) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer (Section D) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer (Section G) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer Contact steve kachocki
5302 betsy ross drive
santa clara , CA 95054
(877) 586 -3647

Device Event Key 1873412
MDR Report Key 1837191
Event Key 1738789
Report Number 2914019-2010-00042
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/13/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 09/14/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number IPL
Device Catalogue Number GAL150000
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer 07/27/2007
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 08/17/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 06/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/14/2010 Patient Sequence Number: 1


"It is a good thing to learn caution from the misfortunes of others."

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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Oct 11, 2010 9:20 am

Lumenis Vasculite device:

LUMENIS LTD. YOKNEAM VASCULIGHT INTENSE PULSE LIGHT DEVICE Back to Search Results

Model Number GA2600000
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
Reasonable attempts were made to obtain add'l info from the user facility, however none was provided. The subject device was last serviced by lumenis on (b)(6) 2009. At that time, the technical subject matter expert observed that calibration was within 5% of manufactured specifications which is within acceptable limits. It was further observed at the time that the treatment head was reaching the end of its serviceable life and should be replaced. A review of sales records concluded that no replacement treatment head was purchased from lumenis. No info regarding the incident date, pt's reported permanent impairment, or the details of the treatment were provided, therefore, no root cause could be determined. Should add'l info be reported a f/u mdr will be filed.


Event Description
It was reported by an attorney that their client, a user facility, was in litigation with a pt who claimed to have sustained scarring after treatment with a vasculight laser.


Search Alerts/Recalls



New Search | Submit an Adverse Event Report

Brand Name VASCULIGHT
Type of Device INTENSE PULSE LIGHT DEVICE
Manufacturer (Section F) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer (Section D) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer (Section G) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer Contact anne hung
5302 betsy ross drive
santa clara , CA 95054
(877) 586 -3647

Device Event Key 1873429
MDR Report Key 1837201
Event Key 1738750
Report Number 2914019-2010-00040
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/13/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 09/14/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number GA2600000
Device Catalogue Number GA2600000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 08/17/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured 06/01/2002
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/14/2010 Patient Sequence Number: 1


"It is a good thing to learn caution from the misfortunes of others."

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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Oct 11, 2010 9:22 am

Lumenis LightSheer:

LUMENIS, INC. LIGHTSHEER DIODE Back to Search Results

Model Number LIGHTSHEER
Event Type Injury
Event Description
It was reported that a pt sustained an adverse reaction and another pt sustained hypopigmentation after hair removal treatment with a lightsheer laser.


Manufacturer Narrative
Reasonable attempts were made to obtain further info from the user facility; however, none was provided. Should additional info be reported, a follow up mdr will be reported. No device malfunction was reported, therefore, no evaluation of the subject device was performed.


Search Alerts/Recalls



New Search | Submit an Adverse Event Report

Brand Name LIGHTSHEER
Type of Device DIODE
Manufacturer (Section F) LUMENIS, INC.
3959 west 1820 south
salt lake city UT 84104

Manufacturer (Section D) LUMENIS, INC.
3959 west 1820 south
salt lake city UT 84104

Manufacturer (Section G) LUMENIS, INC.
3959 west 1820 south

salt lake city UT 84104

Manufacturer Contact annie hung
5302 betsy ross dr
santa clara , CA 95054
(877) 586 -3647

Device Event Key 1849968
MDR Report Key 1821453
Event Key 1724882
Report Number 2914019-2010-00039
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 08/25/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 08/25/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number LIGHTSHEER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 07/29/2010
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 08/25/2010 Patient Sequence Number: 1


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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Oct 11, 2010 9:23 am

Cutera Laser Genesis:

CUTERA LASER GENESIS NONABLATIVE LONG-PULSED 1064-NM ND: YAG LASER Back to Search Results

Model Number 1064-NM ND: YAG
Event Date 07/21/2010
Event Type Injury Patient Outcome Required Intervention; Other
Event Description
I received one treatment of laser genesis -cutera- from dr (b)(6) in (b)(6). Four days later noticed burning in sides of face. This persisted through my vacation the following week where the burning worsened and moved to my scalp and neck and my right arm was numb. I had intense pressure in my head and no tolerance for heat -could not- and still cannot- regulate, i barely sweat-. I was hospitalized in (b)(6) for treatment. Upon return my primary doctor -dr (b)(6), (b)(6)- diagnosed me with nerve damage from the laser. Treatment with neurontin has helped relieve the burning but obviously not a cure when i don't take the medicine. In addition to the burning head which is constant, and the numbness, my skin is scarred, has new lines everywhere, and the pores are huge in places i had no pores. I have no glow in my skin anymore, and people ask me what's wrong/am i sick. I don't even look like myself. Skin still swells constantly. I wish i had never been fooled by the hype of cutera and the cosmetic industry that this is a safe "lunchtime" laser with "no side effects" - and safe for all skin types. I'm left aged, haggard, nerve damaged after one treatment. This product needs to be removed from the market before it causes anymore hard. It's disgraceful and disgusting that there are no warnings for this product. None. I was treated by dr (b)(6) who used 6000 pulses at 13 joules. The recommended settings. Dose or amount: 13 joules. Frequency: 6000 pulses. Route: subdermal. Dates of use: 20 minutes, (b)(6) 2010 - (b)(6) 2010. Diagnosis or reason for use: improve skin tone.


Brand Name LASER GENESIS
Type of Device NONABLATIVE LONG-PULSED 1064-NM ND: YAG LASER
Manufacturer (Section F) CUTERA
san francisco CA

Manufacturer (Section D) CUTERA
san francisco CA

Device Event Key 1843070
MDR Report Key 1813854
Event Key 1717975
Report Number MW5017190
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/19/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 08/19/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number 1064-NM ND: YAG
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?


"It is a good thing to learn caution from the misfortunes of others."

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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Oct 11, 2010 9:25 am

CUTERA TITAN XL

Model Number TITAN XL
Event Type Injury
Event Description
Treatment provider stated that titan xl handpiece had caused a burn. Treatment provider refused to give any treatment information. Treatment provider refused to return the titan xl handpieces back to cutera as required by fda class ii recall. Dates of use: (b)(6) 2008 -- (b)(6) 2010.


Brand Name TITAN XL
Type of Device TITAN
Manufacturer (Section F) CUTERA
brisbane CA

Manufacturer (Section D) CUTERA
brisbane CA

Device Event Key 1839093
MDR Report Key 1810765
Event Key 1715170
Report Number MW5017131
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/16/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 08/16/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Other
Device MODEL Number TITAN XL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 08/16/2010 Patient Sequence Number: 1
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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Oct 11, 2010 9:28 am

Not a patient injury, but interesting. Also, this may not be a cosmetic device (not sure):

IRIDEX CORPORATION IRIDEX OCCULIGHT SLX, AND OTHER IRIDEX LASER OCCULIGHT SLX, AND OTHER IRIDEX LASER SYSTEMS

Model Number SL/SLX
Event Type Malfunction
Event Description
Company, which is a manufacturer of surgical and other medical laser systems, refuses to comply with 21 cfr 1040. 10(h)(2)(ii), and 21 cfr 820. 170, in that company refuses to make available to servicing dealers, distributors, and/or 'others' upon request instructions for assembly, operation, and maintenance, a listing of all controls, adjustments, special tools, and procedures for operation and maintenance, and adequate instructions for service adjustments and service procedures pursuant to 21 cfr 1040. 10(h)(2)(ii), and installation info pursuant to 21 cfr 820. 170 for any of its laser products.


Brand Name IRIDEX OCCULIGHT SLX, AND OTHER IRIDEX LASER
Type of Device OCCULIGHT SLX, AND OTHER IRIDEX LASER SYSTEMS
Manufacturer (Section F) IRIDEX CORPORATION
mountain view CA

Manufacturer (Section D) IRIDEX CORPORATION
mountain view CA

Device Event Key 1832506
MDR Report Key 1802931
Event Key 1708064
Report Number MW5017084
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 08/11/2010
2 DeviceS WERE Involved in the Event: 1 2
1 Patient Was Involved in the Event
Date FDA Received 08/11/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number SL/SLX
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? Yes
Is the Device an Implant? No
Is this an Explanted Device?


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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Oct 11, 2010 9:29 am

TITAN XL

Model Number TITAN XL
Event Date 03/24/2010
Event Type Injury Patient Outcome Other;
Event Description
Patient developed blister on left cheek. Dose or amount: 40j/cm2, route: transdermal. Dates of use: (b)(6) 2007 - (b)(6) 2010.


Brand Name TITAN XL
Type of Device TITAN
Manufacturer (Section F) CUTERA
brisbane CA

Manufacturer (Section D) CUTERA
brisbane CA

Device Event Key 1831959
MDR Report Key 1802798
Event Key 1707942
Report Number MW5017068
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/10/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 08/10/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number TITAN XL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer 06/13/2010
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 08/10/2010 Patient Sequence Number: 1
"It is a good thing to learn caution from the misfortunes of others."

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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Oct 11, 2010 9:31 am

Solta Fraxel RePair

Model Number I WILL EMAIL
Event Date 02/20/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
Fractional laser resurfacing of the face, neck, chest with the fraxel repair laser from solta medical. Treatment was done at standard settings and the pt developed erosions on her neck and chest that healed with permanent scaring. I called solta medical to advise them of this event last spring -spring of 2009-. They said that they -solta- would contact you. As it has been over a year i thought that it would be best to contact you directly. I entered form 3500 for my pt (b)(6) last night from home. I did not have the serial number at home and indicated on the form that i would submit it via email. The machine was produced by (b)(4) (now owned by solta medical, on the form i had indicated solta but should it be listed as (b)(4) as that was the name of the company at the time of purchase in 2008. Although, now the machine is handled by solta because they purchased reliant medical). The machine was built in 2008 and (b)(4). Dose or amount: 20mj, frequency: 20% final-density, route: top. Dates of use: (b)(6)2008 - (b)(6)2010 i still use this laser. Diagnosis or reason for use: usually used for rejuvenation wrinkles.

Brand Name FRAXEL REPAIR LASER
Type of Device FRACTIONAL CO2 LASER, REPAIR LASER
Manufacturer (Section F) SOLTA MEDICAL


Manufacturer (Section D) SOLTA MEDICAL
Device Event Key 1830699
MDR Report Key 1800874
Event Key 1706311
Report Number MW5017054
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 08/09/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 08/09/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number I WILL EMAIL
Device Catalogue Number I WILL EMAIL THIS
OTHER Device ID Number IT IS A LASER
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? Yes
Is the Device an Implant? No
Is this an Explanted Device?


"It is a good thing to learn caution from the misfortunes of others."

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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Oct 11, 2010 9:32 am

Reliant Fraxel ReStore

Event Date 08/01/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
I had laser skin resurfacing done approximately one yr ago. The fraxel restore laser was used. My skin texture has changed for the worse. I have a cobble-stone appearance to my facial skin and my face is extremely sensitive to the sun. This laser needs to be studied further. It is dangerous. Yet, it's marketed as a "safe" treatment.

Brand Name RELIANT FRAXEL
Type of Device FRAXEL RESTORE
Manufacturer (Section F) UNK
unk
unk

Manufacturer (Section D) UNK
unk
unk

Device Event Key 1829037
MDR Report Key 1798792
Event Key 1704412
Report Number MW5017048
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/08/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 08/08/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?


"It is a good thing to learn caution from the misfortunes of others."

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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Oct 11, 2010 9:40 am

Titan Cutera

Lot Number 000
Event Date 06/20/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Had several "titan" ipl treatments. These left me with facial fat loss, indentations in face, tingling sensations in certain areas.

Brand Name TITAN
Type of Device TITAN LASER
Manufacturer (Section F) CUTERA


Manufacturer (Section D) CUTERA


Device Event Key 1817991
MDR Report Key 1782852
Event Key 1690451
Report Number MW5016887
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/24/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 07/24/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Device LOT Number 000
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? Yes
Is the Device an Implant? No
Is this an Explanted Device?


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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Oct 11, 2010 8:29 pm

Lumenis IPL:

LUMENIS LTD. YOKNEAM LUMENIS ONE INTENSE PULSE LIGHT DELIVERY DEVICE

Model Number IPL
Event Date 06/08/2010
Event Type Injury Patient Outcome Other;
Event Description
It was reported that one pt sustained hypopigmentation to the face after ipl treatment with a lumenis one laser and one pt sustained blisters to the back after laser hair removal treatment with a lumenis one laser, lightsheer head. It was further reported that both patients were given licoid lipocream to preclude permanent impairment, the ipl pt is healing well, and f/u was done on the hair removal pt, but no add'l info was provided on the status of their condition.


Manufacturer Narrative
A review of the reported event details by a lumenis medical subject matter expert concluded the probable root cause of the incident occurring to the ipl pt to be inappropriate skin typing by the device operator. Additionally, a lumenis medical matter expert concluded that a test patch was not completed on the area being treated in contraindication to dfu. Reasonable attempts were made to contact the user facility for add'l info regarding the hair removal pt, however, none was provided. Should add'l info be reported, a f/u mdr will be filed. An eval of the subject device by a lumenis technical specialist confirmed that there was no related device malfunction and the device performed within acceptable performance specifications.
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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sat Nov 13, 2010 11:47 am

9/25/2010: http://www.accessdata.fda.gov/scripts/c ... id=1878209

Event Date 09/25/2010
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
After testing of the device and consultation with our service engineer, the conclusion was reached that the device operated according to specifications and no failure detected. Attached is the service report with the results of the energy measurements that were taken from the device. After careful consideration of the testing data and consultation with our service engineer, two things are believed to have caused the incident. This device was being used on the patient for the 1st time. As stated by the doctor, he had previously used another ipl device on the patient. Regardless of the skin type of the patient, a test area should have been completed prior to the procedure. According to the doctor's statement, "the patient did complain of pain and irritation. " the procedure should have been stopped immediately to determine the cause of pain and irritation. The doctor did follow the proper settings but each patient can react differently to each setting. That is why it is necessary to perform a test area prior to any procedure. Attached is a copy of the parameters/settings. Our service engineer reiterated to the doctor/staff the need for performing test areas before each treatment.


Event Description
We were notified on 09/28/2010 of the following incident. According to the doctor: patient has had several treatments for hair removal in the past with another ipl. Patient came in for touch up facial hair removal on (b)(6)2010. Patient is afro-american with skin type 4 and 5. She is light colored. Local skin anesthetic cream was applied for 10 minutes. Ipl settings were set on automatic; hair fine and skin type 5, joules set on 6. Treatment was carried out. Patient did complain of pain and irritation. Immediately after treatment, some areas were red. Two days later, on (b)(6)2010, patient came in with 2nd degree burns on most of the treated areas.

Brand Name APOLLO INTENSE PULSE LIGHT
Type of Device APOLLO IPL
Manufacturer (Section F) SANDSTONE MEDICAL TECHNOLOGIES
102 citation court
homewood AL 35209

Manufacturer (Section D) SANDSTONE MEDICAL TECHNOLOGIES
102 citation court
homewood AL 35209

Manufacturer Contact
105 citation court
homewood , AL 35209

Device Event Key 1911989
MDR Report Key 1878209
Event Key 1775205
Report Number 3003991952-2010-00001
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Unknown
Reporter Occupation Physician
Type of Report Initial
Report Date 10/13/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 10/18/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
OTHER Device ID Number HAND PIECE #23
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 09/01/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse
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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sat Nov 13, 2010 11:50 am

8/26/2010: http://www.accessdata.fda.gov/scripts/c ... id=1852985

ALMA LASERS US ALMA LASER HAIR REMOVAL Back to Search Results

Model Number SOPRANO SERIES
Event Date 08/26/2010
Event Type Injury Patient Outcome Other;
Event Description
I received a laser hair removal treatment at (b)(6) of (b)(6) on (b)(6) 2010. The technician applied double laser pulses on my labia resulting in first and second degree burns with severe swelling and pain. There was a distinct smell of burned hair and flesh, at which the technician remarked "smell that? that means it's working. " this was my third treatment and there was no issue with the first two treatments when a double pulse was not used. "chromo" testing was done prior to setting the equipment and performing the treatment to check the melanin content of my skin. Dates of use: (b)(6) 2010. Diagnosis or reason for use: hair removal - under arms and bikini. Event abated after use stopped or dose reduced?: yes.

Brand Name ALMA
Type of Device LASER HAIR REMOVAL
Manufacturer (Section F) ALMA LASERS US
buffalo grove IL 60089

Manufacturer (Section D) ALMA LASERS US
buffalo grove IL 60089

Device Event Key 1892297
MDR Report Key 1852985
Event Key 1752401
Report Number MW5017656
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 09/26/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 09/28/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Other
Device MODEL Number SOPRANO SERIES
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 09/28/2010 Patient Sequence Number: 1


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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sat Nov 13, 2010 11:52 am

This person has no idea how lucky they might be that it did 'nothing':

http://www.accessdata.fda.gov/scripts/c ... id=1848588

ERCHONIA ZERONA Back to Search Results

Event Type Malfunction
Event Description
(b)(6). I went through the (b)(6) process at dr (b)(6) dermatology office in (b)(6). It did nothing. I paid (b)(6) for no results, after having followed the prescribed regimen. After 12 treatments, they gave me 6 more because it was obvious nothing was happening. I think the fda needs to certify medical providers of the process if it works -not once did the dr come in, check the settings, speak to me or even acknowledge my presence. A technician/esthetician, even the receptionist, attended to all treatments. I believe there is action needed here. Dose or amount: at 40 minute session, frequency: 18 treatments, route: transdermal. Dates of use:(b)(6)2010 - (b)(6)2010. Diagnosis or reason for use: lipo.


Brand Name ZERONA
Type of Device ZERONA
Manufacturer (Section F) ERCHONIA


Manufacturer (Section D) ERCHONIA


Device Event Key 1885973
MDR Report Key 1848588
Event Key 1748561
Report Number MW5017593
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 09/25/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 09/25/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?


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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sat Nov 13, 2010 11:55 am

9/16/2010: http://www.accessdata.fda.gov/scripts/c ... id=1873794

Probably nothing to do with the laser itself, but this lady died from this elective procedure:

OMNI GUIDE INC OMNI GUIDE CO2 LASER CLASS IV LASER Back to Search Results

Model Number LUMENIS 30 C
Event Date 09/16/2010
Event Type Death Patient Outcome Death;
Event Description
Unexpected perioperative mortality (b)(6) female underwent elective excision lip hemangioma. Asaii at initiation of procedure co2 laser applied 5-10 seconds. Immediate subcutaneous emphysema noted - procedure discontinued immediately. Pt vital signs deteriorated - cardiac arrest - despite aggressive resusitation pt expired. Coroner's case.


Brand Name OMNI GUIDE
Type of Device CO2 LASER CLASS IV LASER
Manufacturer (Section F) OMNI GUIDE INC
one kendall square, ste b1301
cambridge MA 02139

Manufacturer (Section D) OMNI GUIDE INC
one kendall square, ste b1301
cambridge MA 02139

Device Event Key 1909119
MDR Report Key 1873794
Event Key 1770790
Report Number MW5017726
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 09/24/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 09/24/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number LUMENIS 30 C
OTHER Device ID Number TOP ASSY #AA0959100
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 09/24/2010 Patient Sequence Number: 1


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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sat Nov 13, 2010 11:57 am

8/31/10: http://www.accessdata.fda.gov/scripts/c ... id=1847652

RH USA, INC. LIGHTSHEER DUET DIODE Back to Search Results

Model Number GASB00000
Event Date 08/31/2010
Event Type Injury Patient Outcome Other;
Search Alerts/Recalls

Brand Name LIGHTSHEER DUET
Type of Device DIODE
Manufacturer (Section F) RH USA, INC.
201 lindbergh avenue
livermore CA 94551

Manufacturer (Section D) RH USA, INC.
201 lindbergh avenue
livermore CA 94551

Manufacturer (Section G) RH USA, INC.
201 lindbergh avenue

livermore CA 94551

Manufacturer Contact annie hung
5302 betsy ross drive
santa clara , CA 95054
(877) 586 -3647

Device Event Key 1884286
MDR Report Key 1847652
Event Key 1747769
Report Number 2914019-2010-00044
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/23/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 09/23/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number GASB00000
Device Catalogue Number GASB00000
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer 09/03/2010
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 08/31/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 04/01/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse


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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sat Nov 13, 2010 12:02 pm

8/1710: http://www.accessdata.fda.gov/scripts/c ... id=1837191

LUMENIS LTD. YOKNEAM LUMENIS ONE ND:YAG SURGICAL LASER DELIVERY DEVICE Back to Search Results

Model Number IPL
Event Date 08/17/2010
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
An eval of the reported event details by a lumenis medical subject matter expert and a review of the dfu concluded the probable root cause to be overlap of pulses on the treatment site in contraindication to dfu.


Event Description
It was reported that a pt sustained a scar to the face following ipl treatment with a lumenis one laser.


Brand Name LUMENIS ONE
Type of Device ND:YAG SURGICAL LASER DELIVERY DEVICE
Manufacturer (Section F) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer (Section D) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer (Section G) LUMENIS LTD. YOKNEAM
13 hayetzira street
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer Contact steve kachocki
5302 betsy ross drive
santa clara , CA 95054
(877) 586 -3647

Device Event Key 1873412
MDR Report Key 1837191
Event Key 1738789
Report Number 2914019-2010-00042
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/13/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 09/14/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number IPL
Device Catalogue Number GAL150000
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer 07/27/2007
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 08/17/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 06/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse
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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sat Nov 13, 2010 12:16 pm

From 2005. I will never find them all. The MAUDE database is a quagmire of nooks and crannies:

http://www.accessdata.fda.gov/scripts/c ... id=1700418

TOTAL CONTROL PTY. LTD. DERMALIGHT 80UV-B WAND / DERMARAT UV-B WAND UV-B 311NM NARROWBAND MEDICAL DEVICES Back to Search Results

Event Date 05/01/2005
Event Type Injury Patient Outcome Required Intervention;
Event Description
In 2005, i used a product called the dermalight 80 uv-b wand for the treatment of psoriasis. I used the dermalight 80 uv-b wand a few times according to the instruction. I stopped using the product immediately after i noticed the severe loss of elasticity to the areas of skin that i applied treatment to. Later, i noticed pain in and damage to my eyes even though i utilized the protective eye-wear. I later returned the product to the mfr. The product is sold and distributed by an (b) (4) company called total control pty. Ltd. They advertise this product, which is now sold under a different name called the dermaray uv wand, on the (b) (4) website. They also advertise similar uv-b devices called the dermaray hair loss laser comb, and even a full body device called the dermaray canopy 10. These products are advertised and sold for the treatment of psoriasis and hair loss on the (b) (4). Our skin is a major organ of our body, and is a part of our intricate organ and endocrine system. This medical uv-b device, the dermalight 80, now called the dermaray, has adversely affected my epidermis in an irreversible way. Which has subsequently, adversely affected my total well-being. The wand emits ionizing uv-b radiation at the wavelength of 311nm. It is thought to be safe because the ionizing energy is emitted in a narrowband or in a straight line, however, this does not take into consideration a total uv-b dose to the entire body over a life time. In other words, once utilizing a uv-b device for treatment of psoriasis on one part of their body can become photosensitive or over-exposed to uv-b radiation overtime as additional exposure to the sun's uv radiation occurs. This is known as cumulative dose. In addition, our scalp protects our brains and is extremely close to our face and eyes, one should never expose their scalp, face, eyes, brain nor their entire body to the extremely ionizing uv-b radiation of the dermalight 80, the dermaray uv wand, the dermaray hair loss laser comb, the dermaray canopy 10 or any other uv-b emitting device. The science behind uv radiation and it's adverse affects on human skin and eyes has been well researched and documented by scientists and researchers. Had i known this science at the time i purchased and utilized the uv-bd device, i would have never have purchased it and used it. As a steward of this earth i am writing this report in hopes of protecting others from using these uv-b devices. In addition, i am asking for the fda to take all uv-b devices for the treatment of skin disorders and hair loss off the market. Mankind had unknowingly contributed to the immense damage of our ozone layer, decades later, we are now knowledgeable and working towards preventing further damage. As the fda is the legal regulating agency for these medical devices, the fda has the responsibility and authority to protect the people of the untied states from hazardous uv-b radiation emitting devices. I ask that the fda not only send out a health alert on these uv-b devices but to take them off the market in the united states.

Brand Name DERMALIGHT 80UV-B WAND / DERMARAT UV-B WAND
Type of Device UV-B 311NM NARROWBAND MEDICAL DEVICES
Manufacturer (Section F) TOTAL CONTROL PTY. LTD.
po box 154
ballajura, western australia
AUSTRALIA 6066

Manufacturer (Section D) TOTAL CONTROL PTY. LTD.
po box 154
ballajura, western australia
AUSTRALIA 6066

Device Event Key 1746563
MDR Report Key 1700418
Event Key 1614732
Report Number MW5016074
Device Sequence Number 1
Product Code FTC
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/23/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 05/23/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Other
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?


"It is a good thing to learn caution from the misfortunes of others."

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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sun Feb 13, 2011 11:42 pm

LUMENIS LTD. YOKNEAM ULTRAPULSE ENCORE AESTHETIC PACKAGE, 100V O.R. MODEL CARBON DIOXIDE SURGICAL LASER Back to Search Results

Model Number ENCORE
Event Date 11/11/2010
Event Type Injury Patient Outcome Other;
Event Description
It was reported a pt sustained scarring below the eyelid after sustaining an infection following laser treatment with a lumenis ultrapulse encore laser. It was further reported the pt was prescribed altabax and diprolene to treat the infection.


Manufacturer Narrative
An examination of the subject device by a lumenis technical expert conducted the system met all required mfr specifications. No related device malfunction was reported or observed. An eval of the reported event details by a lumenis medical subject matter expert conducted the treatment parameters employed were excessive per device labeling and common medical practice for treatment around the eyes.

Brand Name ULTRAPULSE ENCORE AESTHETIC PACKAGE, 100V O.R. MODEL
Type of Device CARBON DIOXIDE SURGICAL LASER
Manufacturer (Section F) LUMENIS LTD. YOKNEAM
13 hayetzira st
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer (Section D) LUMENIS LTD. YOKNEAM
13 hayetzira st
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer (Section G) LUMENIS LTD. YOKNEAM
13 hayetzira st
yokneam industrial park
yokneam
ISRAEL 20692

Manufacturer Contact steve kachocki
3959 west 1820 south
salt lake city , UT 84104
(877) 586 -3647

Device Event Key 2002003
MDR Report Key 1971558
Event Key 1868554
Report Number 1720381-2011-00001
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/25/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 01/24/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number ENCORE
Device Catalogue Number GA5300000
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer 10/09/2010
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 12/21/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 03/01/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 01/24/2011 Patient Sequence Number: 1
# Treatment Treatment Date
WELLBUTRIN RX
2,NEURONTIN RX
"It is a good thing to learn caution from the misfortunes of others."

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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sun Feb 13, 2011 11:44 pm

CANDELA CORP. CANDELA GENTLEYAG LASER DERMATOLOGY LASER Back to Search Results

Event Date 09/08/2009
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
Reported injury occurred on (b)(6) 2009 and candela was notified on (b)(6) 2010. Candela field service engineer installed gentleyag #(b)(4) on (b)(6) 2006 and performed annual preventive maintenance on the laser on (b)(6) 2007, (b)(6) 2008, (b)(6) 2009 and (b)(6) 2009. There are no other calls or inquiries from (b)(6) no known problems with laser system. Customer info: #(b)(6).


Event Description
Insurance company attorney reported a woman was injured during a laser hair removal treatment, when the gentleyag laser that was being used caused severe burning to pt's arms. To date, the pt has circular hypo-pigmented areas on both arms and suffers from severe skin discoloration.

Brand Name CANDELA GENTLEYAG LASER
Type of Device DERMATOLOGY LASER
Manufacturer (Section F) CANDELA CORP.
530 boston post road
wayland MA 01778

Manufacturer (Section D) CANDELA CORP.
530 boston post road
wayland MA 01778

Manufacturer Contact charles morganson
530 boston post road
wayland , MA 01778
(508) 358 -7400 ext 440

Device Event Key 1987917
MDR Report Key 1958372
Event Key 1855368
Report Number 1218402-2010-00001
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/07/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 12/22/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 12/07/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured 10/01/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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DCNGA
 
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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sun Feb 13, 2011 11:45 pm

RH USA, INC. LIGHTSHEER (ALL MODELS) LASER; DIODE Back to Search Results

Model Number DUET
Event Date 10/02/2010
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
Reasonable attempts were made to obtain information from the user facility, distributor, and the attorney including treatment parameters, the severity of the burns, and any preexisting conditions that could affect treatment outcome; however, none were received. The device has not been received by lumenis; therefore, no examination of the subject device has occurred. Should further information about the device or details about the treatments be obtained, a follow-up mdr will be filed.


Event Description
It was reported by an attorney that a patient sustained serious burns to the face following treatment with a lightsheer duet laser. It was further reported that the patient was under the care of a dermatologist.

Brand Name LIGHTSHEER (ALL MODELS)
Type of Device LASER; DIODE
Manufacturer (Section F) RH USA, INC.
201 lindbergh avenue
livermore CA 94551

Manufacturer (Section D) RH USA, INC.
201 lindbergh avenue
livermore CA 94551

Manufacturer (Section G) RH USA, INC.
201 lindbergh avenue

livermore CA 94551

Manufacturer Contact kandy burke
3959 west 1820 south
salt lake city , UT 84104
(877) 586 -3647

Device Event Key 1971287
MDR Report Key 1939700
Event Key 1836696
Report Number 1720381-2010-00059
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial
Report Date 12/15/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 12/16/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Other
Device MODEL Number DUET
Device Catalogue Number GASB00000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 11/15/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured 06/01/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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DCNGA
 
Posts: 5367
Joined: Fri Jun 18, 2010 3:16 pm
Location: US

Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sun Feb 13, 2011 11:46 pm

RH USA, INC. LIGHTSHEER DUET LASER: DIODE Back to Search Results

Model Number DUET
Event Date 09/01/2010
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
Reasonable attempts were made to obtain additional information from the user facility such as treatment settings and patient photos, however, only the description of the adverse event was provided to determine reportability.


Event Description
It was reported that 2 patients sustained 'burns of the skin' following treatment using a lightsheer duet laser system.

Brand Name LIGHTSHEER DUET
Type of Device LASER: DIODE
Manufacturer (Section F) RH USA, INC.
201 lindbergh avenue
livermore CA 94551

Manufacturer (Section D) RH USA, INC.
201 lindbergh avenue
livermore CA 94551

Manufacturer Contact kandy burke
3959 west 1820 south
salt lake city , UT 84104
(877) 586 -3647

Device Event Key 1971433
MDR Report Key 1939708
Event Key 1836704
Report Number 1720381-2010-00060
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 12/16/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 12/16/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number DUET
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 11/17/2010
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
User avatar
DCNGA
 
Posts: 5367
Joined: Fri Jun 18, 2010 3:16 pm
Location: US

Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sun Feb 13, 2011 11:48 pm

RH USA, INC. LIGHTSHEER (ALL MODELS) LASER FIBER DELIVERY DEVICE:DIODE Back to Search Results

Model Number DUET
Event Date 10/16/2010
Event Type Injury Patient Outcome Other;
Event Description
It was reported that a pt sustained second degree burns to the axilla following hair removal treatment with a lighsheer duet laser. It was further reported the pt was expected to sustain transient post treatment hyperpigmentation.


Manufacturer Narrative
No device malfunction was reported, therefore, no device eval occurred. A review of the reported event details, photographs of the pt's injury and reported treatment settings by a lumenis medical subject matter expert concluded the probable root cause to be incorrect treatment settings and a failure to maintain the device by periodically cleaning the treatment head of debris as outlined in device labeling.

Brand Name LIGHTSHEER (ALL MODELS)
Type of Device LASER FIBER DELIVERY DEVICE:DIODE
Manufacturer (Section F) RH USA, INC.
201 lindbergh avenue
livermore CA 94551

Manufacturer (Section D) RH USA, INC.
201 lindbergh avenue
livermore CA 94551

Manufacturer (Section G) RH USA, INC.
201 lindbergh avenue

livermore CA 94551

Manufacturer Contact kandy burke
3959 west 1820 south
salt lake city , UT 84104
(877) 583 -647

Device Event Key 1942985
MDR Report Key 1910972
Event Key 1807968
Report Number 1720381-2010-00056
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/23/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 11/23/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Other
Device MODEL Number DUET
Device Catalogue Number GASB00000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Other
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 10/22/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 03/01/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 11/23/2010 Patient Sequence Number
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
User avatar
DCNGA
 
Posts: 5367
Joined: Fri Jun 18, 2010 3:16 pm
Location: US

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