Dear Nerds: May I Introduce You to MAUDE?

I could only find ONE reference in this entire forum to MAUDE, which is, of course (I say "of course" even though I learned of this just now) the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience Database. So now I want to tell y'all.

"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. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.

An on-line search is available which allows you to search the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE data is current through the end of the previous month. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties."

So if you're curious about your own machine, or thinking of buying a new machine, you can research the adverse events associated with that machine. Notice I said "associated with," not "caused by."

I browsed it a little, and the reports were interesting. You as a consumer can file a report if you wish.

http://www.fda.gov/MedicalDevices/Devic ... 127891.htm

Also, here's the search form: http://www.accessdata.fda.gov/scripts/c ... search.CFM

Wow.. when I first saw the subject of this thread, I was thinking of the TV show.... shows my age...

Sheriff

Sheriff Buford wrote:Wow.. when I fist saw the subject of this thread, I was thinking of the TV show.... shows my age...

Sheriff

Me too Sheriff.

Thanks for the link, DD.

49er

Sheriff:
God will get you for that . . .

Sheriff Buford wrote:Wow.. when I fist saw the subject of this thread, I was thinking of the TV show.... shows my age...

Sheriff

I thought the very same thing when I stumbled on this database.

Thanks for posting this.

My thought was......"Good GOD, MAUDE, what HUGE zip files you have!"


Den

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