Mailed my FDA report 7/9/14; it's still not showing up in+

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.

Mailed my FDA report 7/9/14; it's still not showing up in+

PostPosted by redbysciton » Mon Jul 21, 2014 10:56 pm

the database. I pulled out the instructions for the form and it said the FDA will notify you of its receipt. WTH? Haven't gotten anything from the FDA yet. I had gone right to the PO and had the envelope weighed and mailed right from the PO but did not send certified or tracked. Maybe I should have sprung for the few extra bucks! I called the FDA to see if they had my report and got connected to a person who was not in, so I had to leave VM. Other members: how long did it take until your report showed up in the adverse event database?
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Called FDA again today to ask abt status of my report and+

PostPosted by redbysciton » Tue Jul 22, 2014 11:40 am

got this: "Due to a scheduled event, we are closed at this time. Goodbye." and the line went dead. Huh? Not even a way to leave VM? NO operator???? Not a single soul is in due to this scheduled event? WTH?
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Re: Mailed my FDA report 7/9/14; it's still not showing up i

PostPosted by taija82 » Tue Jul 22, 2014 9:14 pm

Hi I just sent enquiry to the lady who was handling my complaint at Solta, haven't heard anything since I got automated reply she will be out of office during so and so.
Her name is Diane Avoliciano I'll keep you informed if I hear back from her. She might have been going on a holiday but I felt it was weird I received email that day, answered it and automated reply came back. But let's see first what happens.
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Re: Mailed my FDA report 7/9/14; it's still not showing up i

PostPosted by taija82 » Tue Jul 22, 2014 9:15 pm

Keep calling. Squeaky wheels...
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Re: Mailed my FDA report 7/9/14; it's still not showing up i

PostPosted by Erica » Tue Jul 22, 2014 9:17 pm

I know they are severly underfunded..
“It always seems impossible until it's done.” Nelson Mandela
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Update on my FDA report mailed 7/9/14

PostPosted by redbysciton » Wed Jul 23, 2014 3:10 pm

I called FDA and kept trying different menu options until I got a live person. The one that worked was to make a report by phone. The person answering handed me off to a very nice gentleman named Derryck Wilson. He checked the system and said they have no record of it coming in. He offered to accept a scanned copy of my report by email, I did that, and he replied indicating that he got it. Yay! Sheesh, you'd think making the report would be the easy part.

I also asked him where I should direct a more general complaint that the company misrepresents the IPL and fails to disclose certain risks, and he advised me to send a complaint to either / both (1) the Compliance Office of CDRH at FDA, (2) the company's own complaint dept.

The IPL companies USED to have to notify FDA of complaints, now all they have to do is keep records of them in case the FDA comes calling and wants to look at them (hmm, how often do you think they'd be able to do that).

Well, at least I got the report in, and was able to send pdfs of color photos. Small steps, small steps.
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Re: Mailed my FDA report 7/9/14; it's still not showing up i

PostPosted by Erica » Wed Jul 23, 2014 10:39 pm

I admire your tenacity Red!
“It always seems impossible until it's done.” Nelson Mandela
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Re: Mailed my FDA report 7/9/14; it's still not showing up i

PostPosted by redbysciton » Thu Jul 24, 2014 10:49 am

Thanks Erica. I strongly agree w/ the philosophy of this website that everyone who has been harmed by IPL or Laser needs to at least make an adverse event report to the FDA or similar authority in whatever country in which you live. The FDA ONLY acts in response to large #'s of reports. While it usually takes them too long to react, and their reaction is usually not strong enough, if we don't make reports, we 100% guarantee that NOTHING will be done. I am also mindful that every report adds to a database of publicly available knowledge which can only help the state of medical and public knowledge.

I included photos, which made the reporting process more difficult, but if anyone doesn't want to submit photos, the initial reporting is actually very easy. I also want the FDA to have to look at the photos as well, because in the recent stories about power morcellators, an FDA approved device that was belatedly found to drastically increase the risk of causing uterine cancer to spread, it was revealed that this risk was published in the medical literature, but the FDA was completely oblivious to that information because the FDA DOES NOT SEARCH THE MEDICAL LITERATURE for problems. They wait for someone to make a report TO the FDA. Even if there are a million complaints and photos on the internet and medical papers showing complications, the FDA APPARENTLY DOES NOT CONSIDER THAT INFORMATION. They only look at what someone gives to them. So, let's give it to them!

In the IPL device area, I found one FDA-issued bit of information that I THOUGHT was the exception to this, but upon examination, it looks like the FDA merely asked industry for some information on how to prevent "burns" in response to adverse event reports involving burns from IPL. The FDA put the industry-provided information out there as an FDA "safety communication." See http://www.fda.gov/medicaldevices/safet ... 294084.htm

There are some very good safety tips in this "communication," and basic steps like forgetting to add coolant cab be important, overlooked causes of problems. However, this one article is completely inadequate to inform the public or the medical community. It's a start, and I don't criticize the authors because at least they put SOME warning out there, but it focuses only on 2nd degree burns, giving the sense that burns are the only thing you need to worry about. Other side effects are not discussed. It's a good discussion of burns, but much more must be done. Also, it's a reprint of a nursing magazine article and of the 4 references cited in the endnotes, 2 come from Lumenis! None of the papers that members here have located and cited on this website discussing other significant and disfiguring adverse effects are included. And how many doctors and patients are going to read a nursing article? This is why I think the adverse event report is critically important, but we also need to put even more information in front of the FDA's face, hence the eventual complaint letter I am working on w/ articles and resources attached. Hmm, I think I will send that one by email and mail that tracks delivery ....

After my awful IPL experience, I am not anti-laser/IPL - I am against a situation where the medical profession has forgotten its duty to "first, do no harm," and authorities are letting the manufacturers of these devices run amuck, selling machines and treatments to everyone like it's popcorn, and keeping the public AND the medical community in the dark about problems. Industry and medical providers promote these treatments as safe, easy, "no downtime" and effective for just about anyone - a harmless "lunch time procedure" where the risk is so low, it's A-OK to use these treatments for very minor problems. I can decide for myself whether to take a risk, but please inform me fully and accurately before I make that decision. Some patients who have been harmed may want to ban these devices altogether, but I think we can all agree on making the FDA device approval process more than the rubber stamp it now is, giving consumers access to more information so they can make a truly informed decision, and on better educating the medical community on risks and on effective treatments for adverse events.

The lack of medical knowledge on how to effectively treat adverse effects, given the large numbers of people being given these treatments for minor conditions that do not warrant the risks, is truly appalling. If I had known that IPL could seriously exacerbate rosacea and acne, cause MORE and worsened broken blood vessels, and cause depressions, pits, wrinkles, or worsened skin texture, and that every doctor I went to would not be able to offer any effective fix for these adverse effects should they occur, I NEVER would have consented to it to treat the minor problems that I had. The true risks were disproportionately high compared to the minor degree of severity of the problems I was seeking to treat. Furthermore, no doctor I've seen to date has been able to provide me w/ any treatment to effectively address my adverse results, or even to share with me any clinical or research information that could at least better inform me about what I was experiencing. Yes, my outcome could have been much more severe, as I have now seen from pictures of others' burns and scars, but that doesn't mean that I don't have this damage that I paid for without fully understanding the risks.

To everyone here who has shared their story and photos, I applaud your bravery. To everyone whose misery has been compounded by the lack of acknowledgment of the problems caused by these devices and by medical providers who do not know how to effectively treat the effects you have experienced, keep your chins up and keep it loud and proud! Keep up the reporting to the FDA! I also want to thank DCNGA for such wonderful hard work over such a long period. It must be very difficult to sustain efforts over a long time. Thank you DCNGA for your tireless efforts and your deep understanding of the many complex issues at play here. The experience and knowledge shared by members of this board has been extremely helpful to me in dealing with this debacle.
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Re: Mailed my FDA report 7/9/14; it's still not showing up i

PostPosted by redbysciton » Thu Jul 24, 2014 11:02 am

Thanks Taija82. Keep us all posted on how it goes w/ your report.
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Yay! Finally got formal receipt letter from FDA! But also go

PostPosted by redbysciton » Sun Aug 03, 2014 10:12 am

the brush off from Sciton in response to a request to them for complaint contact info! As you may know from my previous posts, I had mailed my FDA Adverse Event Report w/ color photos via regular mail, and never got a receipt letter from the FDA, so I called FDA a few times until I got a person named Derryck Wilson, and he gave me his email address and let me re-file the report w/ photos (and I added more photos!) by email. I then finally got a formal receipt letter in the mail from FDA. Yay!

I also asked Wilson where I should send a complaint re: Sciton making false claims and failing to adequately warn of risks. He said you can send a complaint letter to the FDA's CDRH's Compliance Office and you can send one to the company. He said the company is supposed to have a Complaint process. So, I am going to send a complaint letter to FDA, but also wanted to send one to Sciton. I emailed Sciton, stating I wanted to make a complaint, who do I send it to? Well, this is the utter garbage response I got from Sciton:
____________________________________
From: info@sciton.com
Subject: FW: Patient Complaint
Date: Fri, 1 Aug 2014 14:11:08 +0000

Hello,

Sciton is the equipment manufacturer and is not licensed to practice medicine. Since the clinical practitioner who provided the treatment is licensed to practice medicine and has the necessary experience and the clinical records for the treatment provided to you, we suggest that you contact the practitioner.

Thanks,

info@sciton.com
__________________________

WTH????? I replied:
__________________________
To: Info@sciton.com

Dear Sir/Madam:

It was my understanding that FDA regulations require every device manufacturer to have a mechanism and process for receiving and responding to complaints. Please see the excerpt below copied from the FDA Medical Devices website:

"Complaint Files and Medical Device Reporting
Complaint files are linked to MDR event files because a complaint must be evaluated to determine if it is a reportable adverse event. A complaint is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. Manufacturers and importers are required to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints. Importers are also subject to complaint files because "initial distributors of foreign entities" fall under the definition of a manufacturer in 21 CFR 820.3.

Complaint files that are found to be reportable MDR events should be maintained in a separate portion of the complaint file or otherwise clearly identified."

emphasis added, copied 08/01/14 from http://www.fda.gov/MedicalDevices/Devic ... ault.htm#4

I have forwarded your reply below to the FDA for review. In addition, I have already notified the medical provider who performed the treatment.

Sincerely,

[name and address redacted]
_____________________________
I emailed the whole exchange to Derryck Wilson and said I was concerned the company was trying to evade accepting a complaint and to please forward this to any FDA enforcement office that was appropriate. Hmmm, we'll see if FDA is really interested in protecting the public from shady device mfgs. Looks like Sciton is trying to prevent me from giving them a complaint so they can tell the FDA, we have no complaints on record!

In looking through the FDA AER db, I noticed that although Lumenis always blames something other than their devices, they at least did an investigation of each complaint that LOOKED credible - they would send some1 out to look at the machine, they looked at medical records, they interviewed the provider, etc. I saw none of that w/ Sciton. None of those Lumenis investigations seemed recent. I have to go back and look, and DCNGA might know this like the back of her hand, but didn't the law on reporting and responding to AERs and complaints change at some point, where companies used to have to investigate and respond to each incident to the FDA, and now all they have to do is respond internally (do whatever review they see fit, don't need to notify FDA, just keep it on file so in the unlikely event FDA ever got around to asking to see the records)? Lets' see what Sciton and FDA does next!
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