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Content tagged with Adverse Events

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Report: FDA hiding millions of adverse event reports from docs, public

The FDA is hiding millions of medical device adverse event and malfunction reports from the public, according to a new report from Kaiser Health News.

Surgical staplers and staples linked to 41K+ injury or malfunction reports

FDA said today that it has received more than 41,000 adverse event reports — including 366 deaths — associated with surgical staplers and staples for internal use, and that it may require stricter product review of the devices.