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# Many Device Adverse Reports Hidden From Public: Report
- URL: https://www.fdaweb.com/many-device-adverse-reports-hidden-from-public-report/
- Published: 2019-03-07T12:00:00.000Z
- Updated: 2026-09-15T01:10:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143550

A lengthy Kaiser Health News investigative report says FDA is allowing medical device manufacturers to submit summary adverse event reports to databases that are kept from public view, hindering doctors and researchers who are trying to stay aware of issues with the devices. The [report](https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/?ref=fdaweb.com) details issues with surgical staplers and other devices and includes interviews with doctors, patients, researchers, and former FDA officials, including former commissioner **Robert Califf**, who said he had never heard of the secret databases.

“Since 2016, at least 1.1 million incidents have flowed into the ‘alternative summary reporting’ repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could place patients in jeopardy,” Kaiser says. “Deaths must still be reported in MAUDE. But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to FDA, many implanted in patients or used in countless surgeries. They have included surgical staplers, balloon pumps snaked into vessels to circulation, and mechanical breathing machines.”

FDA spokesperson **Deborah Kotz** told the news agency that the “registry exemption” was created without any public notice or regulations and that “any device manufacturer can request an exemption from its reporting requirements.”

Kaiser Health News says that records provided to it by FDA showed that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.

Former FDA manager **Madris Tome**, who now runs the DeviceEvents Web site, told Kaiser FDA is “basically giving away its authority over device manufacturers. If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.”

Former FDAer **Larry Kessler** said the program took shape around 2000 after scandals over under-reporting of medical device problems spurred changes allowing criminal penalties to be levied against manufacturers. Soon the agency was flooded with reports, he said, and the reports were often so similar that it was difficult to review them. He said the solution was to allow companies to seek a special exemption to avoid reporting certain complications to the public database and instead submit a spreadsheet of injuries or malfunctions each quarter, half-year, or year. That way, Kessler said, reviewers could quickly scan for new problems or spikes in known issues. He said that when the program started, the list of exempted devices was short and was made public. “I don’t know why it’s not \[made public\] now,” he added. “I’m surprised about that.”

Public Citizen Health Research Group director **Michael Carome** said FDA is retreating from making crucial information available for researchers and patients. “It’s just another example of a flawed oversight system,” he said, “bent toward making it easier for industry, rather than making protection of public health the primary goal.”