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Millions of Medical Device Injuries and Malfunctions Hidden from the Public

By Heidi Culbertson

Medical Devices

July 8, 2019   Ohio Dangerous Drugs and Medical Devices, Ohio Legal Updates

By Jessica L. Powell, Burg Simpson Associate

Millions of Medical Device Injuries and Malfunctions Hidden from the Public

 5.7 million reports of device injuries and malfunctions were hidden from the public, according to Kaiser Health News.

Medical device manufacturers are required to notify the FDA about certain device injuries and malfunctions, called “adverse events.” Generally, these adverse events are reported on the FDA’s public database MAUDE. This public database is used by medical professionals, researchers, patients, and others for various things, including evaluating a device’s safety. According to Kaiser Health News (“KHN”), a non-profit healthcare news service, for the past two decades, device manufacturers have been able to bypass MAUDE reporting by submitting “alternative summary” reports to the FDA. The alternative summary reports were housed on a little known, non-public database. As this information was hidden, medical professionals, researchers, and others may not have had access to potentially valuable information.

Thanks to KHN’s investigation, this once hidden information was recently published by the FDA. According to KHN, this information comprised of 5.7 million reports, ranging from inaccurate blood glucose monitors to deaths potentially caused by certain kinds of heart valves. To learn more about KHN’s investigation and findings, click here.

Beyond a doubt, our society has benefitted from medical devices. However, as KHN’s report shows, some devices can be dangerous, even deadly. If you or a loved one have been injured by a medical device, contact one of the experienced medical device attorneys at Burg Simpson’s Cincinnati office today. Our award-winning attorneys would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE, no obligation consultation today.

About Jessica L. Powell:

Jessica Powell focuses her practice on medical malpractice, employment law, business law, personal injury, and mass tort litigation, including lawsuits involving defective pharmaceutical drugs and devices. Jessica is currently significantly involved in the Depakote® (valproic acid) Products Liability Litigation.

Prior to practicing law, Jessica Powell earned her Bachelor of Arts from Eastern Kentucky University, graduating magna cum laude in 2005. She spent over a decade handling disability cases before she pursued her law degree, which she earned from Salmon P. Chase College of Law, graduating summa cum laude, in 2016. Jessica is currently admitted to practice in Ohio and Kentucky.

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