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--Cosmetic Devices

PostPosted by DCNGA » Sun Feb 13, 2011 11:50 pm

LUMENIS LTD. YOKNEAM LUMENIS 1 INTENSE PULSE LIGHT DEVICE:- Back to Search Results

Model Number GAL140000
Event Date 10/07/2010
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
An examination of the subject device by a lumenis technical expert concluded that no related device malfunction occurred. No malfunction was reported by the user facility. An eval of the reported event details and reported treatment settings by a lumenis medical subject matter expert concluded the probable root cause was inappropriate treatment settings employed by the device operator for the condition being treated in contradiction to training and dfu.


Event Description
It was reported that a pt sustained scarring in two spots on the face following ipl treatment for brown spots with a lumenis one laser. It was further reported the pt was treated with bacitracin.

Brand Name LUMENIS 1
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 kandy burke
3959 west 82 south
salt lake city , UT 84104
(877) 586 -4647

Device Event Key 1942970
MDR Report Key 1910973
Event Key 1807969
Report Number 1720381-2010-00058
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 Health Professional
Device MODEL Number GAL140000
Device Catalogue Number GAL140000
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer 10/25/2010
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 10/25/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 10/01/2006
Is The Device Single Use? 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: 1
# Treatment Treatment Date
1,NA
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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sun Feb 13, 2011 11:52 pm

SCITON SCITON SCITON LASER Back to Search Results

Lot Number 000
Event Date 04/09/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description
Went to a plastic surgery office to get a laser peel -sciton. The office of dr (b)(6) assured me that the laser would make the skin turn red for 3 to 4 days, the result was a massive peel for 8 days. My skin has continued to develop deep lines and open pores. It is very dry and resulted in inflammation to the bottom layer of the skin. Currently, my dermatologist has put me on prescription strength cortisone to stop the severe inflammation. The dermatologist expressed that due to the laser, there is a chance i may never be able to use products or exfoliants again as a result to the laser burn. Dose or amount: 20 microns, frequency: 20 microns, route: dates of use: (b)(6) 2010. Diagnosis or reason for use: skin treatment.

Brand Name SCITON
Type of Device SCITON LASER
Manufacturer (Section F) SCITON


Manufacturer (Section D) SCITON


Device Event Key 1933910
MDR Report Key 1899861
Event Key 1796857
Report Number MW5018180
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/10/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 11/10/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device LOT Number 000
OTHER Device ID Number 0000
Was Device Available For Evaluation? No
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?



---Page Last Updated: 01/31/2011
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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sun Feb 13, 2011 11:53 pm

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

Model Number GASB00000
Event Date 10/10/2010
Event Type Injury
Manufacturer Narrative
An on-site examination of the subject device by a lumenis authorized distributor rep concluded the reported issue could not be duplicated. An eval of the reported event details by a lumenis technical subject matter expert concluded that system safety circuits would have prevented the device operator from treating the pt should the reported issue have occurred. Reasonable attempts were made to obtain further info from the initial rptr regarding the name of the user facility, pt info, treatment settings, and sequela however none was rec'd. Lumenis is unable to make a determination of root cause at this time. Should further info be provided a f/u mdr will be filed.


Event Description
It was reported that a pt sustained second degree burns and blisters to the face after hair removal treatment with the lumenis lightsheer duet. It was further reported that the system was not cooling.

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

Device Event Key 1938076
MDR Report Key 1907215
Event Key 1804211
Report Number 2914019-2010-00054
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/10/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 11/10/2010
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 11/05/2010
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 10/10/2010
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

Patient TREATMENT DATA
Date Received: 11/10/2010 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 » Sun Feb 13, 2011 11:54 pm

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

Model Number GASB00000
Event Date 09/29/2010
Event Type Injury
Event Description
It was reported that a pt sustained second degree burns after hair removal treatment with the lightsheer duet, et handpiece, and is in the process of healing. It was further reported that the cooling button had turned off during treatment although the device operator had not touched the screen.


Manufacturer Narrative
An on-site examination of the subject device by a lumenis authorized distributor rep concluded that the reported issue with the cooling button could not be duplicated. An evaluation of the reported event details by a lumenis technical subject matter expert concluded that system safety circuits would have prevented the device operator from treating the pt should the reported issue have occurred. An evaluation of the reported treatment settings and a photograph of the pt's adverse reaction by a lumenis medical subject matter expert concluded the treatment settings employed were within acceptable parameters. Lumenis is unable to make a determination of root cause at this time. Should further info be provided, a follow-up mdr will be filed.

Brand Name LIGHTSHEER DUET
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 (Section G) 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 1939107
MDR Report Key 1907050
Event Key 1804046
Report Number 2914019-2010-00053
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/09/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 11/09/2010
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 11/05/2010
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 10/10/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 05/01/2010
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: 11/09/2010 Patient Sequence Number: 1
# Treatment Treatment Date
1,NA



---
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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sun Feb 13, 2011 11:55 pm

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

Model Number GASB00000
Event Date 09/30/2010
Event Type Injury
Manufacturer Narrative
A review of the reported event and photographs of the pt by a lumenis medical subject matter expert concluded the root cause to be failure on the part of the device operator to perform a test patch for the model of laser employed during treatment as outlined in device labeling and to adjust treatment settings for the model of laser employed during treatment. Updated treatment settings were supplied with the device at the time of installation. An evaluation of the subject device by a lumenis technical expert concluded the device performed within manufacturer specifications. No device malfunction was reported or observed.


Event Description
It was reported that a pt sustained burns and scabs to the legs following treatment using a lightsheer duet, et handpiece. It was further reported the device operator employed treatment settings for an older model of lightsheer laser without having performed a test patch with the new subject device.

Brand Name LIGHTSHEER DUET
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 (Section G) RH USA, INC.
201 lindbergh ave

livermore CA 94551

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

Device Event Key 1928835
MDR Report Key 1897630
Event Key 1794626
Report Number 2914019-2010-00052
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial
Report Date 11/05/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 11/05/2010
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 10/28/2010
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 10/07/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 05/01/2010
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 Initial

Patient TREATMENT DATA
Date Received: 11/05/2010 Patient Sequence Number: 1
#
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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Sun Feb 13, 2011 11:57 pm

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

Model Number GAL170000
Event Date 10/05/2010
Event Type Injury
Event Description
It was reported that a patient sustained blisters on the left calf after hair removal treatment with a lumenis one laser.


Manufacturer Narrative
Reasonable attempts by phone and fax were made to obtain treatment settings, patient info, and medical intervention info, however, none was received. An examination of the subject device by a lumenis technical subject matter expert concluded that no related device malfunction occurred and that the device operated within mfr specifications. A review of service records concluded that the user facility had the device serviced within a year. Lumenis is unable to determine a root cause for the reported event.

Brand Name LUMENIS ONE
Type of Device INTENSE PULSE LIGHT DEVICE
Manufacturer (Section F) LUMENIS LTD., YOKNEAM
13 hayetzira st.
yokneam indust. park
yokneam
ISRAEL 20692

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

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

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

Device Event Key 1928004
MDR Report Key 1895468
Event Key 1792460
Report Number 2914019-2010-00050
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/04/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 11/04/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number GAL170000
Device Catalogue Number GAL170000
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer 10/25/2010
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 10/05/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 01/01/2008
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: 11/04/2010 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 » Sun Feb 13, 2011 11:58 pm

LUMENIS, LTD. LUME 2 INTENSE PULSE LIGHT DEVICE Back to Search Results

Model Number GA-0005000
Event Date 10/04/2010
Event Type Injury
Event Description
It was reported that a patient sustained blisters on the arms after ipl treatment with an lume 2 laser. It was further reported that the lume 2 laser was a demo unit on loan to the user facility.


Manufacturer Narrative
Reasonable attempts were made by phone and e-mail to obtain treatment settings, patient info, and medical intervention info, however, none was provided. An examination of the subject device by a lumenis technical subject matter expert concluded no related device malfunction occurred and that the device operated within mfr specifications. A review of service records of the demo unit concluded that the device had been serviced within a year. Lumenis is unable to determine a root cause for the reported event.

Brand Name LUME 2
Type of Device INTENSE PULSE LIGHT DEVICE
Manufacturer (Section F) LUMENIS, LTD.
yokneam, 13 hayetzira st.
yokneam indust. park
yokneam
ISRAEL 20692

Manufacturer (Section D) LUMENIS, LTD.
yokneam, 13 hayetzira st.
yokneam indust. park
yokneam
ISRAEL 20692

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

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

Device Event Key 1928009
MDR Report Key 1895486
Event Key 1792482
Report Number 2914019-2010-00051
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/04/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 11/04/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number GA-0005000
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer 11/01/2010
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 10/04/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 07/01/2010
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: 11/04/2010 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 » Sun Feb 13, 2011 11:59 pm

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

Model Number ENCORE
Event Date 03/23/2009
Event Type Injury Patient Outcome Other;
Event Description
It was reported by an attorney that their client sustained serious burn injuries to the neck and chest, shock, and injuries to the nervous system, after treatment performed with a lumenis ultrapulse laser.


Manufacturer Narrative
Reasonable attempts were made to obtain treatment settings, pt info, subject device serial number, and service history records from the user facility, however none was received. A review of service records concluded the reported user facility did not obtain the subject device from lumenis directly, nor does the facility maintain a service contract with lumenis. Without the subject device serial number, lumenis is unable to determine the status of the device. Lumenis is therefore unable to determine a root cause for the reported event. Although no info was provided by the user facility about the service history of the device, lumenis cannot rule out that service by authorized third party service providers may have contributed to the reported adverse event. To the best of lumenis' knowledge, the subject device remains in use at the user facility.

Brand Name ULTRAPULSE ENCORE AESTHETIC PACKAGE
Type of Device CARBON DIOXIDE SURGICAL LASER
Manufacturer (Section F) LUMENIS LTD. YOKNEAM
13 hayetzira st
yokneam indust pk
yokneam
ISRAEL 20692

Manufacturer (Section D) LUMENIS LTD. YOKNEAM
13 hayetzira st
yokneam indust pk
yokneam
ISRAEL 20692

Manufacturer (Section G) LUMENIS LTD YOKNEAM
13 hayetzira st
yokneam indust pk
yokneam
ISRAEL 20692

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

Device Event Key 1924641
MDR Report Key 1892347
Event Key 1789343
Report Number 2914019-2010-00048
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 10/27/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 10/27/2010
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 0642-415-01
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 10/05/2010
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: 10/27/2010 Patient Sequence Number: 1
# Treatment Treatment Date
1,UNK
"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 Apr 25, 2011 8:43 pm

Event Date 05/07/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
Physician performed limelight treatment to upper back, shoulders, chest and face. Pt was diagnosed with "first and second degree burns" resulting is "scars". The limelight handpiece was out of specification. Dose, frequency and route used: b - 16-18j transdermal.


Manufacturer Narrative
The pt received a burn, although the extent of the burn is not clear. The doctor does indicate in an email that the pt was scarred. The handpiece was out of specification on all settings. No clear root cause was determined when evaluated by cutera.


Search Alerts/Recalls



New Search | Submit an Adverse Event Report

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

Manufacturer (Section D) CUTERA
brisbane CA

Manufacturer Contact
3240 bayshore blvd
brisbane , CA 94005
(415) 657 -5700

Device Event Key 2014773
MDR Report Key 1982696
Event Key 1879691
Report Number 2954354-2011-00003
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/02/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 02/03/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 05/13/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 12/10/2007
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: 02/03/2011 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 Apr 25, 2011 8:44 pm

/LUMENIS ULTRAPULSE ULTRAPULSE LUMENIS 5000C CO2 Back to Search Results

Event Date 12/29/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
Dr (b)(6) of (b)(6) scarred my face and neck with an ultrapulse co2 laser, changing the texture of my skin to a raised striated/grid pattern. Pigment and tissue were lost, and there was nerve damage. Members of the dr's staff stated that my injuries were commonly seen with the use of this device. It is also widely known to be unsafe within the medical community. One chair of dermatology at the (b)(6) stated that scarring and loss of pigment were seen in as many as 30% of cases. Device manufacturers have responded to known risks and complications by developing new technologies to replace the early generation ultrapulse. However, some drs, like dr. (b)(6), are not making the investment in safer technologies, but continuing to put people at risk, and injure many. After the injury, the dr at first denied use of an early generation ultrapulse, when asked, telling me that a lumenis ultrapulse encore with active fx was used. My injuries and recovery were entirely inconsistent with encore with active fx, and this is a laser the dr did not own. When challenged, the dr then reported that the coherent ultrapulse 5000c was used. According to their records, lumenis hasn't serviced dr. (b)(6)'s ultrapulse for 5 years, whereas it should be serviced every year. The dr did not report my injuries as required to lumenis. I made the report to them, but find no reference to my case in the maude database.


Search Alerts/Recalls



New Search | Submit an Adverse Event Report

Brand Name ULTRAPULSE
Type of Device ULTRAPULSE LUMENIS 5000C CO2
Manufacturer (Section F) COHERENT/LUMENIS
palo alto CA

Manufacturer (Section D) COHERENT/LUMENIS
palo alto CA

Device Event Key 2031041
MDR Report Key 1998791
Event Key 1895787
Report Number MW5019444
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/16/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 02/16/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? Yes
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?
"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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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Apr 25, 2011 8:45 pm

Event Date 10/10/2010
Event Type Injury
Event Description
Diagnosis: rosacea; has laser procedure done annually for treatment of rosacea, usually tried a different laser, however, dermatologist recommended a different treatment this year (ipl procedure). Almost immediately following treatment noticed indentations in skin + decreased facial volume. Laser should not be on the market.


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Brand Name SCITON BROADBAND LIGHT
Type of Device LASER LIGHT
Manufacturer (Section F) SCITON


Manufacturer (Section D) SCITON


Device Event Key 2027114
MDR Report Key 1994993
Event Key 1891989
Report Number MW5019424
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 02/06/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 02/16/2011
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 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: 02/16/2011 Patient Sequence Number: 1
"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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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Apr 25, 2011 8:46 pm

LUMENIS, LTD. YOKNEAM LUMENIS 1 LUMENIS ONE INTENSE PULSE LIGHT DELIVERY DEVICE Back to Search Results

Model Number IPL
Event Date 11/30/2010
Event Type Injury Patient Outcome Other;
Event Description
Pt underwent photofacial treatment to her face using lumenis one ipl delivery device under the proper settings for her skin type, fitzpatrick iv, using the lumenis pre-programmed default settings in the lumenis one for a fitzpatrick iv level. Pt was without complaints upon leaving the clinic. However, several hours following her treatment, pt called the clinic concerned for multiple areas of redness. It was requested that the pt returned to the clinic that day for assessment and potential treatment, however, pt was unwilling to come in that day. The pt did return to the clinical the following day on (b)(6) 2010, and saw the physician assistant. It was noted that the pt sustained multiple areas of first degree burns to the face with the most prominent area being the forehead with a potential of a 2nd degree burn to the forehead, however, no blistering, ulcerations, nor fragile skin noted in this area. Pt was prescribed triluma and asked to return to clinic for oxygen treatment and f/u with pa/md. An appointment was made for pt to return on (b)(6) 2010. Subsequently, pt cancelled her appointment stating that she was under the care of her own physician. It is unk at this time what the outcome has been from this adverse event as the pt would not longer return to our clinic for treatment.


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Brand Name LUMENIS 1
Type of Device LUMENIS ONE INTENSE PULSE LIGHT DELIVERY DEVICE
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

Device Event Key 2064706
MDR Report Key 2030561
Event Key 1927536
Report Number MW5019910
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial
Report Date 03/21/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 03/21/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number IPL
Device LOT Number 191
Was Device Available For Evaluation? Yes
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?
"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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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Apr 25, 2011 8:47 pm

, LTD. YOKNEAM QUANTUM SOLID STATE AESTHETIC LASER Back to Search Results

Model Number QUANTUM
Event Date 02/10/2011
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
Reasonable attempts were made to obtain info including treatment settings, pt photos and degree of burn from the user facility; however, none were received. An examination of the subject device including tests of all output specs by lumenis design engineers concluded the device performed within acceptable mfr specs. An examination of device labeling concluded the probable root cause to be performance of a procedure contraindicated in device labeling.


Event Description
It was reported that a pt sustained a burn following treatment with a lumenis quantum laser. It was further reported that the pt failed to return to the user facility for f/u examination. No info regarding the degree of burn or the condition of the pt was reported.


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Brand Name QUANTUM
Type of Device SOLID STATE AESTHETIC LASER
Manufacturer (Section F) LUMENIS, LTD. YOKNEAM
13 hayetzira st.
yokneam business park
yokneam
ISRAEL 20692

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

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

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

Device Event Key 2050514
MDR Report Key 2017843
Event Key 1914839
Report Number 3004135191-2011-00006
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/10/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 03/10/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number QUANTUM
Device Catalogue Number GA3691000
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer 02/10/2011
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
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 12/01/2010
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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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Apr 25, 2011 8:48 pm

LUMENIS, LTD. QUANTUM SR INTENSE PULSE LIGHT DELIVERY DEVICE Back to Search Results

Model Number SR
Event Date 04/08/2009
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
A review of service records for the subject device concluded the device had been serviced regularly and had been examined and evaluated within one month of the reported event date and found to meet manufacturer specifications. The subject device had been regularly serviced by a lumenis technical specialist according to manufacturer recommendations. An evaluation of the reported treatment parameters by a lumenis healthcare professional concluded the parameters were within acceptable guidelines per device labeling and common medical practice concluding the probable root cause of the reported event to be the reported double-pass over the area being treated.


Event Description
It was reported that a patient sustained burns after treatment with a lumenis quantum laser. It was further reported by the patient that during the treatment the device operator was interrupted by a visitor to the treatment room and that upon reinitiating treatment the operator went over the same areas multiple times. It was further reported that follow-up treatments, constituting medical intervention, were employed by the facility to preclude permanent impairment.


Brand Name QUANTUM SR
Type of Device INTENSE PULSE LIGHT DELIVERY DEVICE
Manufacturer (Section F) LUMENIS, LTD.
yokneam industrial park
p.o.b. # 240
yokneam,
ISRAEL 20692

Manufacturer (Section D) LUMENIS, LTD.
yokneam industrial park
p.o.b. # 240
yokneam,
ISRAEL 20692

Manufacturer (Section G) LUMENIS, LTD.
yokneam industrial park
p.o.b. # 240
yokneam,
ISRAEL 20692

Manufacturer Contact steven kachocki
3959 west 1820 south
salt lake city , UT 84104
(801) 656 -2357

Device Event Key 2062864
MDR Report Key 2031996
Event Key 1928971
Report Number 3004135191-2011-00008
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Health Professional
Type of Report Initial
Report Date 03/25/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 03/28/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator PHYSICIAN ASSISTANT
Device MODEL Number SR
Device Catalogue Number GA3600000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer 03/12/2009
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age 7 yr
Event Location Outpatient Treatment Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 03/23/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 05/28/2002
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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Re: MAUDE Adverse Reaction Filings--Cosmetic Devices

PostPosted by DCNGA » Mon Apr 25, 2011 8:50 pm

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

Model Number ET
Event Date 09/03/2010
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
An eval of the reported event, treatment settings, and photographs of the pt by a lumenis health professional concluded the probable cause of the event to be excessive treatment settings employed for the pt's skin type in contradiction to common medical practice.


Event Description
It was reported that a pt sustained a scar to the upper lip as a result of hair removal treatment with the lumenis lightsheer laser.
"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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Re: MAUDE Adverse Event Reporting--Cosmetic Devices

PostPosted by DCNGA » Wed Jan 18, 2012 4:14 pm

From October to December 31, 2011:

CUTERA 1064NM ND: YAG XEO EXCEL LASER 1064NM ND: YAG LASER Back to Search Results

Event Date 04/29/2011
Event Type Injury Patient Outcome Required Intervention; Other
Manufacturer Narrative
On (b)(6) 2011: vascular treatment #2 for diagnosis of "rosacea". The 1064nm nd: yag infrared laser (s/n: (b)(4)) was used for both the laser genesis treatment and vascular treatment to the skin. The xeo series of systems can be used to treat vascular lesions by the process of selective photothermolysis. When treating vascular lesions, the blood temperature at the targeted area is elevated to a level that causes coagulation w/o damage to the epidermis or surrounding tissue. Since the 1064nm nd: yag laser energy is absorbed by melanin in the epidermis, as well as the desired target of hemoglobin, the epidermal cooling feature integrated in the handpiece is used to reduce the temperature rise in the epidermis. The prevent damage to the surrounding tissue, tissue cooling should be performed before and after the light pulse. Surface cooling improves safety. The pre and post continuous contact cooling time with the copper tip of the cutera 1064nm nd: yag laser is generally from a few seconds to less than 1 min during a laser vascular treatment. The calibrated tip temperature of the copper tip for the cutera nd: yag 1064nm laser is 4 degrees celsius in "ready" mode. The copper cooling tip is not used during the laser genesis treatment. The handpiece is kept is constant motion. There were no error codes. The -3 degree celsius tip temperature could not have caused or contributed to a cold burn injury w/o having been in constant contact with the affected skin for greater than 20 mins with no warming measures. The skin temperature was elevated with each of the 78 pulses that were delivered to the treatment area by the nd: yag 1064nm laser. The pt treatment record reflects that "78" pulses were delivered during the vascular treatment.


Event Description
On (b)(6) 2011: doctor's office telephoned cutera to report adverse event "cold burn" after vascular treatment to the chin of a pt with "rosacea". Treatment date was (b)(6) 2011. The "cold burn" resulted in a "keloid scar" per the doctor's office report.

Brand Name 1064NM ND: YAG XEO EXCEL LASER
Type of Device 1064NM ND: YAG LASER
Manufacturer (Section F) CUTERA

brisbane CA

Manufacturer (Section D) CUTERA

brisbane CA

Manufacturer Contact renee lierly, rn
3240 bayshore boulevard
brisbane , CA
(415) 657 -5731

Device Event Key 2310808
MDR Report Key 2287575
Event Key 2184471
Report Number 2954354-2011-00020
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Other
Reporter Occupation NOT APPLICABLE
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 10/06/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 10/06/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 09/19/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 01/01/2009
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 Invalid Data

Patient TREATMENT DATA
Date Received: 10/06/2011 Patient Sequence Number: 1
# Treatment Treatment Date
LASER GENESIS TREATMENT AND LASER VASCULAR
2,TREATMENT TO FACE WITH 1064NM ND: YAG LASER


=======

SYNERON AND CANDELA EPRIME SYSTEM FROM SYNERON AND CANDELA IS A MINIMALLY INVASI EPRIME SKIN REJUVENATION PROCEDURE Back to Search Results

Event Date 04/26/2011
Event Type Injury Patient Outcome Required Intervention;
Event Description
I had an eprime skin rejuvenation procedure performed on my face on (b)(6) 2011. It was performed by the dermatologist specializing in laser and skin rejuvenation procedures. The representative from syneron was assisting during this procedure. Syneron is a manufacturing company which sells ablative and non-ablative medical aesthetic devices including eprime device. The dermatologist injected 4 shots of anesthesia and applied anesthesia cream on my skin before the procedure. When my skin became numb, the doctor performed procedure with a minimally invasive aesthetic device (eprime). Right after the procedure, my face began to swell but the doctor and representative stated it was normal. Within the hour, my face became twice bigger in size, was covered in bright red dots and i was unable to open my mouth and eyes. The doctor assured me that it was normal and recommended to keep ice pack on my face. I followed the instructions. After one more hour, i went to the emergency room at the hospital where i received shots of benadryl, steroids, pain relief medication and iv. My face did not changed in shape it was still swollen. Next day, i went to see my dermatologist who performed the procedure, she gave me another shot of steroid and prescribed prednisol. At night, my face was more swollen so i had to go to the emergency room again, where i received decadron, benadryl and pepcid injections. My face became a little bit less swollen. Next morning, my face was twice bigger in shape, red, navy blue in color with bruises and lots of wrinkles, my neck and shoulders swollen. Dates of use: (b)(6) 2011.


Brand Name EPRIME SYSTEM FROM SYNERON AND CANDELA IS A MINIMALLY INVASI
Type of Device EPRIME SKIN REJUVENATION PROCEDURE
Manufacturer (Section F) SYNERON AND CANDELA


Manufacturer (Section D) SYNERON AND CANDELA


Device Event Key 2316739
MDR Report Key 2296500
Event Key 2193396
Report Number MW5022601
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/07/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 10/07/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Health Professional
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? Yes
Is the Device an Implant? No
Is this an Explanted Device?

=========

LUMENIS, LTD. LUMENIS ONE INTENSE PULSE LIGHT DELIVERY DEVICE: IPL Back to Search Results

Model Number LUMENIS ONE
Event Date 03/24/2010
Event Type No Answer Provided Patient Outcome Other;
Event Description
It was reported by a patient on the fda voluntary medwatch system (b)(4) that they sustained signs of fat necrosis, lines, dilated pores, ice pick scars, dents, redness, [and] burning within the first month post ipl treatment with a lumenis one laser.


Manufacturer Narrative
A lumenis representative contacted the initial reporter to investigate the event report. During a telephone conversation, the initial reporter declined to disclose the facility, device operator, or details of the reported event. Insufficient information is provided in the initial report to complete an investigation of the event report and to determine a cause. Should additional information be provided to lumenis with which to determine a cause for reported event, lumenis will file a follow-up mdr.

Brand Name LUMENIS ONE
Type of Device INTENSE PULSE LIGHT DELIVERY DEVICE: IPL
Manufacturer (Section F) LUMENIS, LTD.
6 hakidma street po box 240
yokneam industrial park
yokneam, israel
ISRAEL 20692

Manufacturer (Section D) LUMENIS, LTD.
6 hakidma street po box 240
yokneam industrial park
yokneam, israel
ISRAEL 20692

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

salt lake city UT 84104

Manufacturer Contact steven kachocki
3959 west 1820 south
salt lake city , UT 84104
(801) 586 -3647

Device Event Key 2286464
MDR Report Key 2267396
Event Key 2164292
Report Number 3004135191-2011-00051
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Consumer,Other
Reporter Occupation Patient
Type of Report Initial
Report Date 09/28/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 09/28/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number LUMENIS ONE
Device Catalogue Number GAL1700000
Is The Reporter A Health Professional? No
Device Age
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 09/21/2011
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 Unkown

==================================
PALOMAR MEDICAL TECHNOLOGIES, INC. ASPIRE PLATFORM Back to Search Results

Model Number 0300-1000
Event Date 01/01/2010
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
At the time of device installation the distributor confirmed both devices were working within specifications. Additionally, (b)(6) post installation the distributor also verified both devices were operating within specifications. Both device facilities as well as the treating physician believe the devices operated as intended over the course of the year. After reviewing several of the cases with physicians trained in plastic surgery, it was believed these incidents occurred as a result of poor suction technique and were unrelated to the laser system. The physician is no longer using these devices. According to the user facilities none of the patients were hospitalized and did not experience infection. Patients skin discoloration is improving post peels and microderm abrasion. Scarring is also improving with silicon pad applications.


Event Description
Over the course of a year multiple patients were treated by the same physician in (b)(6). Complications were reported between two different locations each having their own device. Reported complications included: poor results and contour deformities in approximately 35 patients. Necrosis and scarring in approximately 10-15 patients. Skin color changes in approximately 20-30 patients and one patient experienced burn. Both devices operated within specification and performed as intended. With the exception of the burn, poor suction technique post laser treatment is thought to be the cause of complications.


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Brand Name ASPIRE PLATFORM
Manufacturer (Section F) PALOMAR MEDICAL TECHNOLOGIES, INC.
15 network dr.
burlington MA 01803

Manufacturer (Section D) PALOMAR MEDICAL TECHNOLOGIES, INC.
15 network dr.
burlington MA 01803

Manufacturer Contact steven armstrong, svp
15 network dr.
burlington , MA 01803
(781) 993 -2300

Device Event Key 2345395
MDR Report Key 2326193
Event Key 2223069
Report Number 1223483-2011-00002
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/21/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 11/03/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number 0300-1000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 09/24/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured 08/01/2009
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 Unkown

Patient TREATMENT DATA
Date Received: 11/03/2011 Patient Sequence Number: 1
# Treatment Treatment Date
1,TUMESCENT/ANESTHESIA

============================

LUMENIS LTD M22 INTENSE PULSE LIGHT DELIVERY DEVICE Back to Search Results

Model Number M22
Event Date 10/03/2011
Event Type Injury Patient Outcome Other;
Event Description
It was reported that a patient sustained a second degree burn to the face following ipl treatment with a lumenis one laser.


Manufacturer Narrative
No device malfunction was reported by the initial reporter; therefore, no device evaluation occurred. Device malfunction is not the suspected cause of the event reported. A lumenis healthcare professional evaluated patient treatment records and photograph concluding the root cause of the event to be operator error: incorrect treatment tip for the size of the area being treated and aggressive treatment settings employed in contradiction to device training and device ifu. Additionally, the healthcare professional concluded that the event would likely result in a small scar. No malfunction suspected.


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Brand Name M22
Type of Device INTENSE PULSE LIGHT DELIVERY DEVICE
Manufacturer (Section F) LUMENIS LTD
yokneam industrial park
p.o.b. # 240
yokneam,
ISRAEL 20692

Manufacturer (Section D) LUMENIS LTD
yokneam industrial park
p.o.b. # 240
yokneam,
ISRAEL 20692

Manufacturer (Section G) LUMENIS LTD
yokneam industrial park
p.o.b. # 240
yokneam,
ISRAEL 20692

Manufacturer Contact brett godfrey
3959 west 1820 south
salt lake city , UT 84104

Device Event Key 2355847
MDR Report Key 2337267
Event Key 2234143
Report Number 3004135191-2011-00054
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 11/15/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 11/15/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Physician
Device MODEL Number M22
Device Catalogue Number GA-005000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Device Age
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 10/12/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured 01/02/2011
Is The Device Single Use? Yes
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

================================

CUTERA, INC. TITAN XL Back to Search Results

Event Date 02/09/2010
Event Type Injury Patient Outcome Required Intervention; Other
Manufacturer Narrative
The area sales mgr performed the treatment. Cutera clinical guidelines recommend using ultrasound gel, topical anesthetic used instead of ultrasound gel. The topical anesthetic was not removed prior to treatment as instructed in cutera guidelines. Cutera titan guidelines stated the following info regarding topical anesthetic: these treatment can be tolerated without anesthesia. The use of sedation, nerve blocks, or local injectable anesthetics is not recommended for these treatments as pt feedback is very important, and with proper technique, is not required. Topical anesthesia can be used if desired. It must be completely removed prior to treatment. Caution: toxicity may result with overuse of topical anesthesia. Consult the mfr's labeling.


Event Description
Burns, blisters after titan treatment. Titan handpiece evaluated, found to be operating within specification.


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

Manufacturer (Section D) CUTERA, INC.
brisbane CA

Manufacturer Contact renee lierly, rn
3240 bayshore blvd
brisbane , CA 94005
(415) 657 -5731

Device Event Key 2372718
MDR Report Key 2350309
Event Key 2247165
Report Number 2954354-2011-00032
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/21/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 11/22/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer 02/22/2010
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 02/09/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 09/01/2004
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

===============================================

CUTERA VANTAGE 1064NM ND:YAG LASER Back to Search Results

Event Date 11/01/2011
Event Type Injury Patient Outcome Required Intervention;
Event Description
The following info was sent by email by user facility: i am having inconsistent results with the cutera vantage nd:yag laser which i am borrowing at another drs. I have treated warts since last (b)(6) and sometimes get the black dry mark and the wart is gone. Very effective and no hassle or wound for the pt. About half the time using the same setting, i get a blister, abscess, tissue breakdown. I treated four pts and one pt had this horrific result within hours. Large hematomas that become large masses. He's on crutches. This was done under 2% xylocaine and i used only one to two pulses over the area. Tried not to overlap much.


Manufacturer Narrative
The doctor borrowed the laser from another physician. Cutera requested laser serial number, location of laser and treatment info. The doctor requested adverse event report to be emailed to her. This report was emailed to physician. The physician did not know the laser serial number. The physician has not responded to cutera's request for info.


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Brand Name VANTAGE 1064NM ND:YAG LASER
Type of Device 1064NM ND:YAG LASER
Manufacturer (Section F) CUTERA
brisbane CA

Manufacturer (Section D) CUTERA
brisbane CA

Manufacturer Contact renee lierly, rn
3240 bayshore blvd
brisbane , CA
(415) 657 -5731

Device Event Key 2381590
MDR Report Key 2358463
Event Key 2255319
Report Number 2954354-2011-00031
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 11/23/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 11/23/2011
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? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 11/15/2011
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

==================================================

LUMENIS LTD LUMENIS ONE INTENSE PULSE LIGHT DELIVERY SYSTEM Back to Search Results

Model Number LUMENIS ONE
Event Date 11/02/2011
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
An examination of the subject device by a lumenis technical expert concluded the device operated to manufacture specifications. Calibration was found to be within acceptable limits. No device malfunction was reported or observed. A lumenis healthcare professional evaluated the reported event details concluding the probable cause of the events to be failure to perform a test patch to determine appropriate treatment settings prior to treatment in contradiction to device labeling and common medical practice.


Event Description
It was reported that three patients sustained second degree burns and blisters to the abdomen, neck and chest respectively following hair removal treatment with a lumenis one laser. No test patch was reportedly performed on the patients prior to treatment. No medical intervention was reported to preclude permanent impairment.


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Brand Name LUMENIS ONE
Type of Device INTENSE PULSE LIGHT DELIVERY SYSTEM
Manufacturer (Section F) LUMENIS LTD
yokneam industrial park
p.o.b. # 240
yokneam,
ISRAEL 20692

Manufacturer (Section D) LUMENIS LTD
yokneam industrial park
p.o.b. # 240
yokneam,
ISRAEL 20692

Manufacturer (Section G) LUMENIS LTD
yokneam industrial park
p.o.b. # 240
yokneam,
ISRAEL 20692

Manufacturer Contact brett godfrey
3959 west 1820 south
salt lake city , UT 84104

Device Event Key 2373715
MDR Report Key 2353244
Event Key 2250100
Report Number 3004135191-2011-00056
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 11/30/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 11/30/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Physician
Device MODEL Number LUMENIS ONE
Device Catalogue Number GAL-14000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Device Age
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 11/09/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 06/01/2007
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

==============================================

CANDELA CORP. GENTLEMAX DERMATOLOGY LASER Back to Search Results

Model Number 9914-00-0402
Event Date 11/04/2011
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
The unit that was utilized for this treatment was loaned to the user site, since the unit that the user site owned was being repaired. The product device history record and service history for the loaned unit were reviewed (b)(6) 2011 with no conclusions made. The treatment parameters reportedly used by the operator were: 18 mm spot size, 3 ms pulse duration, (b)(6) dcd setting which are within the parameters for skin type iv, which the user site believed was the skin type of the pt.


Event Description
It was reported to candela corporation on (b)(6) 2011, that a female pt received laser hair removal treatment on her underarms and reported burns on the treated area. The pt was reported to have gone to te emergency room the night after the treatment and claimed to have first degree burns.


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Brand Name GENTLEMAX
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 (Section G)




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

Device Event Key 2401067
MDR Report Key 2378477
Event Key 2275333
Report Number 1218402-2011-00007
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type User facility
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 12/13/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 12/13/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number 9914-00-0402
Device Catalogue Number 9914-00-0402
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 11/15/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured 07/01/2007
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

=================================

CANDELA CANDELA V-BEAM Back to Search Results

Event Date 04/29/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description
Rn at (b)(6) used improper settings to treat my telangiectasia. My skin was blackened and i had blistering. I know the scarring is permanent at this point because i'm almost two years out.


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Brand Name CANDELA
Type of Device V-BEAM
Manufacturer (Section F) CANDELA


Manufacturer (Section D) CANDELA


Device Event Key 2407769
MDR Report Key 2386607
Event Key 2283463
Report Number MW5023527
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/18/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 12/18/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
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?

================================================

UV LIGHT Back to Search Results

Event Type Injury Patient Outcome Other;
Event Description
I received, in a dermatologist's office uv light treatment for vitiligo: puva twice a week (psolaren 20 mg ultra), total approx 102 treatments from (b)(6) 1997 to (b)(6) 1999; uvb narrow band twice a week, total approx 213 treatments from (b)(6) 1999 to (b)(6) 2001. Adverse event: i have been diagnosed with malignant melanoma in (b)(6) 2007 and (b)(6) 2011.


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Type of Device UV LIGHT
Device Event Key 2413290
MDR Report Key 2390192
Event Key 2287027
Report Number MW5023587
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/10/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 12/22/2011
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?

Patient TREATMENT DATA
Date Received: 12/22/2011 Patient Sequence Number: 1
# Treatment Treatment Date
ELIDEL (PIMECROLIMUS) CREAM 1%
5,PROTOPIC (TACROLIMUS OINTMENT 0.1%)

CUTERA 1064NM ND: YAG LASER Back to Search Results

Model Number XEO NAVIGATION
Event Date 02/07/2011
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Dr's office states that pt rec'd a total of "443" pulses to upper and lower, anterior and posterior legs. Dr. 's office reports that pt did not develop or report any incidents in this anatomical area. Treatment settings for legs were recorded as "(b)(4)". Left nare was recorded as "(b)(4)"; number of pulses = "10". Dr's office reports pt "had clear drainage for left side of the nose" that resulted in a "scar". The treatment provider reports using "laser genesis and pearl fractional" laser treatments to treat the scar. The treatment reports that the area "has resolved" with no further intervention. There were no reported blisters or adverse events experienced on the legs after 443 pulses were applied. Pt reported "1 scar" on "left nare", 10 pulses were applied to the area. The device did not malfunction during the treatment. The laser was serviced 10 months prior to the reported adverse event and then was not serviced again until 3 months after the reported adverse event. This is a reportable event as evidenced by the dr's report that the injury required "laser genesis and pearl fractional" laser treatment as interventions to prevent permanent impairment of the body structure (left nare). The scar has resolved per the dr's report.


Event Description
On (b)(6) 2011: the physician's office manager telephoned cutera reporting a pt developed "a blister that resulted in a scar" after receiving a laser vascular treatment with nd: yag 1064nm laser to "left side of the nose". The office manager reported the area "has resolved with laser genesis and pearl fractional treatments".


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Brand Name 1064NM ND: YAG LASER
Type of Device 1064NM ND: YAG LASER
Manufacturer (Section F) CUTERA

brisbane CA

Manufacturer (Section D) CUTERA

brisbane CA

Manufacturer Contact renee lierly, rn
3240 bayshore blvd.
brisbane , CA 94005
(415) 657 -5731

Device Event Key 2311361
MDR Report Key 2287591
Event Key 2184487
Report Number 2954354-2011-00021
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 10/04/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 10/06/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number XEO NAVIGATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 09/19/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured 01/01/2009
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
"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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Re: MAUDE Adverse Event Reporting--Cosmetic Devices

PostPosted by hopeful19 » Sat Jan 21, 2012 7:06 pm

SCITON SCITON BROAD BAND LIGHT SCITON BBL Back to Search Results

Model Number UNKNOWN
Event Date 05/22/2008
Event Type Injury Patient Outcome Other;


Event Description
I had sciton bbl performed on my face and chest for pigment spots. I now have facial scarring and fat loss over my entire face. I also have damage to the skin on my chest and fat loss there as well. Date of use: 2008. Diagnosis: pigment spots.



Brand Name SCITON BROAD BAND LIGHT
Type of Device SCITON BBL
Manufacturer (Section F)
SCITON
Manufacturer (Section D)
SCITON
Device Event Key 1331716
MDR Report Key 1271227
Event Key 1213158
Report Number MW5009295
Device Sequence Number 1
Product Code GEX
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/10/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 12/10/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number UNKNOWN
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?
"There's almost no risk involved," says Stephen Fanning, CEO of Solta Medical, which owns Fraxel.

The world is a dangerous place to live, not because of the people who do evil, but rather those who sit back & let it happen.
-Einstein
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