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Flexi-Seal Control never submitted for regulatory review
According to the FDA, ConvaTec began marketing and distribution of the device without seeking regulatory review.
Although the company manufactured similar devices in the past, the recalled Flexi-Seal CONTROL Fecal Management System was significantly different from the previous versions and would have needed a 510(k) application submission to be considered for approval by the FDA.
Over a period of a year, the FDA has noted 13 adverse event reports in which the use of the Flexi-Seal CONTROL Fecal Management System has resulted in serious injury or death. Adverse events cited by the FDA include necrosis, ulceration, peeling skin, rectal damage, and death.