Medical Device Failures Brought To Light Now Bolster Lawsuits And Research
Millions of injuries and malfunctions once funneled into a hidden Food and Drug Administration database are now available.
FDA Ends Months-Long FOIA Battle Over Medical Device Failures, Says Putting Database Online ‘Satisfies’ KHN Request
KHN filed multiple Freedom of Information Act requests over months, and the FDA responded Wednesday saying the data about device malfunctions is now publicly available online.
More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database
The FDA reveals that 56,000 malfunctions associated with surgical staplers weren’t reported through its traditional public reporting system.
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.