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FDA releases six million defective medical device records

Hidden adverse event reports secretly filed by device manufacturers now public
June 24, 2019
The FDA released hidden records of defective medical devices

For decades the FDA allowed medical device manufacturers to file “adverse event” reports of defective and harmful medical devices in a database that is only accessible by FDA employees. Adverse events reports contain information on device complications and malfunctions resulting in patient injury, pain and suffering and death. Since 1997 this database, called the Alternative Summary Reporting (ASR) program, effectively hid this critical data pertaining to the safety and efficacy of hundreds of implanted devices from patients and physicians. Until June 21, 2019, thirteen manufacturers were permitted to file ASR reports.

So, how transparent is this newly public information?  There are 15 zip files on the FDA website:  

Here is an example of what you will see when you open one ofthe files as an Excel document (it’s pretty unreadable in the default .txtfile). Included in this file are devices such as a hip replacement, pacemakers, catheters, IVC filters and breast implants made by DePuy, Cook, Osteonics, Zimmer and others:

A sample file from the FDA's Device Experience Network Report

Well, it’s a start. You can learn more about these hidden files by viewing this report from KVUE. To read the FDA’s announcement, read their June 21, 2019 Statement.

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Medical Device Watch is sponsored by Wilentz, Goldman & Spitzer, P.A. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.

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