12 Hospitals Cited by FDA for Failing to Report Medical Device Safety Issues

12 Hospitals Cited by FDA for Failing to Report Medical Device Safety Issues

By |2019-05-24T07:03:48+00:00November 9th, 2016|Blog Posts in 2016, News Blog|0 Comments

According to an article recently published by NPR, The Food and Drug Administration (FDA) has concluded that several major hospitals throughout the country are failing to accurately report patient deaths or injuries related to defective medical devices. As revealed in the FDA’s most recent hospital inspection report, reporting lapses were found in 12 hospitals surveyed throughout the country, including well-known facilities such as Cedars-Sinai Medical Center, Massachusetts General Hospital, and New York-Presbyterian Hospital.

The observed failed reporting practices are believed be indicative of a much larger issue throughout the medical industry, likely due to both a lack of awareness of medical device complications and poor training of medical professionals regarding proper FDA reporting requirements. Under federal law, hospitals are required to report serious injuries caused by medical devices to the manufacturer and inform both the manufacturer and the FDA of any deaths that may have been caused by a device. Serious issues which require immediate action to prevent public harm must be reported to the FDA within five days. Shockingly, some of the observed hospitals took between 10 and 18 months to report device-related deaths, with some of them failing to report issues at all.

Defective Medical Device Attorney

While medical devices such as pacemakers, prosthetics, and implants are designed with the intention of performing life-saving medical functions, these same devices can cause serious injury to their recipients if they are not properly tested before being brought to market or are otherwise defective.

Commonly harmful medical devices include:

If you have been injured by a defective medical device, you may have grounds to pursue full and fair monetary compensation from the manufacturer or hospital for your resulting losses. At Kaiser Gornick LLP, our team of San Francisco product liability lawyers have successfully secured hundreds of millions in compensation on behalf of injured clients and can provide the powerful representation you need to maximize your potential recovery.

Call or contact us online today to discuss your legal options in full.

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