Kaiser Health News: 7 Things to Know About the FDA's Hidden Medical Device Database

1. 5.7 million medical device injury and/or malfunction incidents bypassed FDA's public database into an alternative summary reporting system over 20 years. The FDA recently released its data.
2. Blood glucose meters for patients with diabetes had the most incidents in the database, with 2.4 million reports over the past 20 years.
3. There were 2.1 million reports for bad dental implants, 114,200 of which were reported last year.
4. There were 176 deaths reported through the alternative summary reporting system.
5. Surgical stapler-related malfunctions accounted for more than 66,000 previously hidden incidents since 2001.
6. Breast implant injuries and malfunctions accounted for nearly half a million reports over 20 years, including implants that leaked, deflated or migrated.
7. The FDA is replacing alternative summary reporting with the Voluntary Summary Reporting Program. Over 5,600 device types (87%) are eligible for summary reporting of device malfunctions.

Notes: from the article, "Five Things We Found In The FDA’s Hidden Device Database," by Sydney Lupkin
Source: Kaiser Health News, June 27, 2019
Source URL: https://khn.org/news/five-things-we-found-in-the-fdas-hidden...

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