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Flexi-Seal CONTROL Fecal Management System Lawsuits
If you or a loved one were injured by a recalled or defective fecal management device, Carabin Law is prepared to help. Safety alerts issued by the U.S. Food and Drug Administration (FDA) warn that defects in the Flexi-Seal CONTROL Fecal Management System (FMS) may cause the device to dislodge unexpectedly, leading to catastrophic injuries.
According to the FDA, failures involving the device’s valve system can result in rectal trauma, tissue death (necrosis), infection, and even death. These injuries often occur in already vulnerable hospital patients who are unable to protect themselves or report early warning signs.
Allegations Against the Manufacturer
Federal regulators allege that ConvaTec, the manufacturer of the Flexi-Seal CONTROL, marketed and distributed the device without required FDA clearance.
The FDA determined that although ConvaTec previously sold similar products, the Flexi-Seal CONTROL included significant design differences that required regulatory review before being sold to hospitals and healthcare facilities.
Specifically, the FDA states the device should have undergone a 510(k) premarket submission, a mandatory process used to evaluate whether a medical device is safe and substantially equivalent to legally marketed devices.
Failure to Obtain FDA Clearance
According to FDA findings:
ConvaTec began selling the Flexi-Seal CONTROL without submitting it for regulatory review
The device was not cleared or approved before being used on patients
Design changes increased the risk of device expulsion and internal injury
Hospitals were allegedly unaware of the increased dangers
Marketing a medical device without proper FDA authorization can expose patients to unnecessary and undisclosed risks, forming the basis for product liability and mass tort claims.
Reported Injuries and Adverse Events
Over a one-year period, the FDA documented at least 13 serious adverse event reports tied to the Flexi-Seal CONTROL FMS. Reported complications include:
Device expulsion during use
Rectal tears and perforation
Severe ulceration and skin breakdown
Tissue necrosis
Infection and sepsis
Death
Because these devices are often used in intensive care or long-term care settings, patients may not realize a malfunction occurred until life-threatening complications develop.
Injured? Contact Carabin Law
If you were harmed by the Flexi-Seal CONTROL Fecal Management System or another defective medical device, Carabin Law is ready to stand up for you.
Contact Carabin Law today for a FREE, confidential case review.
Our attorneys represent injured patients across Texas.