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What was found in the FDA’s "hidden" device database?


After two decades of keeping the public in the dark about millions of medical device malfunctions and injuries, the US Food and Drug Administration (FDA) has published the once hidden database online, revealing 5.7 million incidents publicly for the first time.

The newfound transparency follows a Kaiser Health News investigation that revealed device manufacturers, for the past two decades, had been sending reports of injuries or malfunctions to the little-known database, bypassing the public FDA database that’s pored over by doctors, researchers and patients. Millions of reports, related to everything from breast implants to surgical staplers, were sent to the agency as “alternative summary” reports instead.

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Source: Kaiser Health News, June 27 2019

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