Deaths associated with some transcatheter valve-repair procedures may be underreported in a US Food and Drug Administration (FDA) adverse events database, leaving a misleading picture of the number of ...
More than 1 million medical device adverse event reports sent to the US Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between September 2019 ...
Cryolipolysis accounted for a majority of noninvasive cosmetic procedures associated with adverse events, according to an analysis of data from the Manufacturer and User Facility Device Experience ...
A significant number of medical device adverse events that resulted in patient deaths were miscategorized in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database, according to ...
Nearly 10% of postmarket device safety reports in MAUDE were submitted over 6 months after the safety event occurred. Manufacturers are supposed to report to the passive surveillance database within ...
After two decades of keeping the public in the dark about millions of medical device malfunctions and injuries, the Food and Drug Administration has published the once-hidden database online, ...
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