Finally rec'd my FDA adverse report # from FDA+

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.

Finally rec'd my FDA adverse report # from FDA+

PostPosted by redbysciton » Thu Aug 21, 2014 10:39 am

Still waiting for my report to show up in FDA online db (now searchable at www.fdable.com). So, mailing and then emailing my report and pix in, it took about a month and several phone calls to get my report to the point where I rec'd written confirmation of receipt and a case # from the FDA. I'm hoping that folks who filed online had a quicker and easier process!

I haven't gotten around to finishing up my general complaint (about false advertising, dangerousness, Sciton's refusal to accept a patient complaint, request for investigation and enforcement). Been busy at work, and I am compiling a BUNCH of exhibits for that letter. This is the address I was given by the FDA Ombudsman on where to send that complaint: OCMedicalDeviceCo@fda.hhs.gov

The Ombudsman who responded to my query on Sciton's refusal to accept my complaint was:

David S. Buckles, PhD, FACC
CDRH Ombudsman
10903 New Hampshire Avenue, WO32-4282
Silver Spring, MD 20993
301-796-5447

He did offer to file a complaint w/ Office of Compliance on my behalf, but I declined and said I'd just submit the complaint myself to the email address he gave me. I did email him back asking if he was the Ombudsman for industry or for patients, or both, and if he was for industry, why wasn't there one for patients? I didn't see a response to that question.
redbysciton
 
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Re: Finally rec'd my FDA adverse report # from FDA+

PostPosted by taija82 » Thu Aug 21, 2014 12:03 pm

Well I checked my complaint on the fdable.com
And it was there under fraxel dual.
And interestingly this was under my complaint:

THE OPERATOR MANUAL LISTS SCARRING AND TEXTURAL CHANGES AS COMPLICATIONS THAT MAY BE ASSOCIATED WITH THE NON-ABLATIVE LASER SYSTEM. SCARRING: THE POSSIBILITY FOR SCARRING EXISTS EVENT WITH NON-ABLATIVE FRACTIONAL LASER DEVICES SUCH THE FRAXEL 1550, FRAXEL 1927 AND FRAXEL DUAL 1550/1927 LASER SYSTEMS. LOCAL SCARRING MAY OCCUR DIRECTLY FROM LASER EXPOSURE IF TREATMENT PROCEDURES ARE NOT FOLLOWED PROPERLY, OR FROM INFECTION OR PHYSICAL IRRITATION SUCH AS PICKING AND RUBBING. DELAYED WOUND HEALING/ SKIN TEXTURAL CHANGES: FOLLOWING LASER TREATMENT, RE-EPITHELIZATION MAY NOT OCCUR AS EXPECTED DUE TO PATIENT PHYSIOLOGY, I.E. POOR WOUND HEALING ABILITY, OR POST-TREATMENT CARE. THIS MAY RESULT IN UNDESIRABLE TEXTURAL CHANGES. THE MFR WAS UNABLE TO REACH THE PHYSICIAN TO OBTAIN ANY ADD'L INFO REGARDING THE TREATMENT OF THIS PATIENT. THE MFR WAS UNABLE TO DETERMINE THE CAUSE OF THIS CASE.
THE PT ALLEGES THAT THE FOURTH TREATMENT IN A SERIES OF NON-ABLATIVE LASER TREATMENTS CAUSED "PERMANENT ATROPHIC SCARRING" IN THE TREATED AREA. PT REPORTS THE TREATED AREA IS COVERED IN LASER HOLES FROM THE TREATMENT; "DAMAGE RESEMBLES LARGE PORES" AND IN THE NON-TREATED AREA THE SKIN IS NORMAL. THE INDICATION FOR TREATMENT IS UNK TO THE MFR.



Never was I mentioned any of those side effects. Also they apparently could t reach my physician either not surprised the little prick..
taija82
 
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Re: Finally rec'd my FDA adverse report # from FDA+

PostPosted by redbysciton » Sat Aug 23, 2014 9:31 am

Wow Taija82, what a worm that guy is! Wouldn't even RESPOND to an inquiry? Weasel! It would be interesting if you reported him to his medical board just to see him have to answer a complaint! WEASEL
redbysciton
 
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