And then there's MAUDE

FDAble also provides clients with adverse event and malfunction information for medical devices using the FDA's MAUDE database. MAUDE is an acronym for Manufacturer and User Facility Device Experience Database. I think we can all agree that this is a horrible name, unless you are a fan of Bea Arthur

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The MAUDE database is weird in so many ways (more about that in a future post), but one of its remarkably nice features is that it provides a free-form narrative describing the problem associated with each report. In contrast to MAUDE, the FDA does not provide the narratives for FAERS data (unless you file a FOIA request and are willing to wait about 1 month).

From the looks of it, the FDA currently receives about 80-90 thousand MAUDE reports per month (which is roughly the same magnitude as the number of FAERS reports received per month as well). You can also see that MAUDE recently celebrated its 300th month anniversary (starting in December of 1991).

The FDA started including manufacturer reports in August of 1996, which explains the giant leap in the # of reports at that time.