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Study: Nearly 30% Of Device Adverse Event Reports Don’t Meet Deadline

 
• By Elizabeth Orr

Data recently published in The BMJ found that almost 30% of device adverse event reports filed with the US FDA are late or missing accurate date information. A relatively small number of companies account for more than half of the late reports.

Businessman standing on a clock sinking in water. Concept: Time pressure, Deadline.
(Elnur/Shutterstock)

The US Food and Drug Administration’s ability to monitor early device safety signals may be hampered by late reporting of device adverse events, research published this week in The BMJ argues.

The study, performed by a team of researchers led by Washington University of St

Key Takeaways
  • About 30% of device adverse events reported to the FDA’s MAUDE database between 2019 and 2022 either were filed late or lacked date information.
  • The number was driven by late reports from a handful of manufacturers, including Abbott, Medtronic and BD

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