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1 death, 12 injuries may be linked to defective medical device

Nashville, like many other cities in the country, is home to many healthcare facilities that provide round-the-clock care. These establishments often rely heavily on medical devices and medicines to care for their patients and trust that these products are safe for use. When one of these products is found to be defective, a recall is often initiated to ensure that potential injuries and deaths are avoided.

A defective medical product may have caused 1 death and 12 serious injuries. The deaths and injuries were reported between February 2013 and March 2014.

The product in question—the Flexi-Seal CONTROL Fecal Management System—is a device used to contain fecal matter for patients who suffer from acute fecal incontinence. The device is manufactured by ConvaTec, a medical product company with a global presence.

ConvaTec has determined that these devices’ defects may lead to problems involving valve leaks and inflation/deflation issues. The company has also established that death and serious injury can occur as a result of using this product. Resulting health hazards include skin deterioration due to fecal soiling, rectal damage and device leakage.

It has not yet been definitively established that the 13 reported incidents were caused by Flexi-Seal CONTROL FMS.

When defective medical devices result in negative health implications or fatalities, the injured parties or their families may want to pursue civil claims against the manufacturers responsible for the defect. Those who wish to learn more about what this process entails may want to seek the advice of an attorney.

Source: FDA.gov, “FDA Classifies ConvaTec’s Voluntary Global Recall of Flexi-Seal CONTROL Fecal Management System (FMS) as Class I,” July 3, 2014 

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