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:
Subject: FW: Patient Complaint
Date: Fri, 1 Aug 2014 14:11:08 +0000
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.
WTH????? I replied:
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.
[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!