The FDA reveals that 56,000 malfunctions associated with surgical staplers weren’t reported through its traditional public reporting system.
Category: Medical Devices
Hidden Reports Masked The Scope Of Widespread Harm From Faulty Heart Device
The Food and Drug Administration allowed one company to send 50,000 reports of harm or malfunctions to an internal database even as patients worried about faulty defibrillators lodged in their hearts.
FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices
In the wake of a KHN investigation, the agency will no longer let device makers file reports of harm outside a widely used public database.
FDA Chief Calls For Release Of All Data Tracking Problems With Medical Devices
In the wake of a KHN investigation, Scott Gottlieb says releasing the records is in the public interest.
Device-Safety Experts To FDA: Make Data Public
For almost two decades, device makers have sent reports of incidents to databases hidden from public view.
FDA Announces Sweeping Plan To Review Safety Of Surgical Staplers
The FDA said it might reclassify the widely used devices featured in a recent Kaiser Health News investigation.
Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices
The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, leaving doctors and medical sleuths in the dark.
Podcast: KHN’s ‘What The Health?’ New Year, New Health Proposals
Democratic governors and mayors are unveiling new ideas to control costs and expand coverage. The federal government shutdown has spared most health agencies, but not all. And learn the latest on that lawsuit out of Texas, which is threatening the Affordable Care Act once again. Margot Sanger-Katz of The New York Times, Anna Edney of Bloomberg News and Rebecca Adams of CQ Roll Call join KHN’s Julie Rovner to discuss these issues and, for “extra credit,” provide their favorite health policy stories of the week. Rovner also interviews KHN’s Jordan Rau about the latest “Bill of the Month.”
Refund On The Way To Latest ‘Bill Of The Month’ Patient
Ski buff Sarah Witter will get $6,358.26 back from her hospital and insurer after a careful review of her bill following the KHN-NPR story on her case.
After Her Skiing Accident, An Uphill Battle Over Snowballing Bills
She took a bad fall on the slopes and her surgeon used a metal plate to put the splintered bones of her leg back together. When that device failed less than four months later, she and her insurer had to pay full price for the replacement plate.
