Seems there were two separate data bases. One open to the public and the other classified.
After two decades of keeping the public in the dark about millions of medical device malfunctions and injuries, the Food and Drug Administration 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.
Here’s what we found in those newly public reports:
1. Blood glucose meters for patients with diabetes had more unique incidents than any other device in the database, logging 2.4 million reports over the past 20 years.
2. There were 2.1 million reports for bad dental implants. And 114,200 were reported last year.
3. There were 176 deaths reported through the alternative summary reporting system.
4. Surgical stapler-related malfunctions accounted for more than 66,000 previously hidden incidents since 2001.
5. Breast implant injuries and malfunctions accounted for nearly half a million unique reports over two decades, including implants that leaked, deflated or migrated.
All sorts of details @ 5 things found in the FDA's hidden device database
