June 20, 2013 — ConvaTec, Inc., has issued a Class I recall for the Flexi-Seal CONTROL Fecal Management System Kit because it was not legally marketed and it has been linked to 13 severe adverse events, including one death.
The fecal management kit is used in bedridden, immobilized, and incontinent patients. The kit consists of a soft catheter, which is inserted into a patient’s rectum to divert waste into a containment bag.
The device is designed to keep bedding clean, protect skin and wounds from fecal contamination, and reduce the risk of infection.
Unfortunately, the U.S. Food and Drug Administration (FDA) has discovered numerous problems with the Auto-Valve feature, which is supposed to control the inflation and deflation of the device’s retention balloon. The Auto-Valve may fail to limit inflation to 45mL, leak at the inflation port, or prevent the balloon from inflating/deflating.
Health risks of using this device include:
- Rectal damage (necrosis/ perforation/ulceration or bleeding)
- Expulsion of the device and/or leakage
- Fecal soiling of bed linen/incontinence pads leading to skin deterioration around the anus
- Peeling skin
- Raw, irritated lesions due to skin contact with fecal matter
Do I have a Fecal Management Kit Lawsuit?
The Schmidt Firm, PLLC is currently accepting ConvaTec Flexi-Seal Fecal Management System induced injury cases in all 50 states. If you or somebody you know has been injured by bleeding, infection, or other side effects, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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