Discovery of "hidden" FDA database of malfunctions

#1
Does anyone know what this is referring to? I have come across it a couple of times now, and I seriously feel so out of touch!

A “Hidden” Registry of Device Malfunctions & Injuries
FOI Services' collection of FDA documents acquired under the Freedom of Information Act includes over 85,000 files covering drugs, devices, biologics and other FDA-regulated products...but we’ve never come across mention of the medical device malfunction/injury registry described in a March 7, 2019 report published by Kaiser Health News, the Tampa Bay Times, and the Miami Herald:
…the FDA had quietly granted the makers of surgical staplers a special ‘exemption’ allowing them to file reports of malfunctions in a database hidden from doctors and from public view.

On investigation, the article’s authors found a “vast and hidden repository of reports” describing incidents NOT individually reported to MAUDE. The reports are not limited to staplers – the alternate system includes “about 100” devices exempt from public reporting, including intra-aortic balloon pumps, pacemaker electrodes and implantable defibrillators.
To read and evaluate the report yourself, visit: [had to eliminate the live link as part of Elsmar Cove restrictions]

The website also provides instructions for republishing the article without violating copyright restrictions, so you can easily distribute the content to your colleagues.
 

Marc

Captain Nice
Staff member
Admin
#2
[had to eliminate the live link as part of Elsmar Cove restrictions]
FYI - Anyone can put in a link. If the poster doesn't have the 10 minimum posts (restriction is to keep spammers at bay) to put in a "live" link, you (or anyone) can put in, for example, website dot com or website dot com /<whatever>. One of us will see it and make it a live link if appropriate.
 

Ronen E

Just a person
Staff member
Super Moderator
#5
Sounds a little on the conspiracy-theory-side to me, at least until I see something more solid that "I spoke to FDA and came to find out that..."

To me it doesn't look like FDA is hiding anything related to surgical staplers, on the contrary: Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers

I wonder if it's just a coincidence that this comes out at the same time as the FDA's letter.
 

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