June 20, 2014 — The U.S. Food and Drug Administration (FDA) has issued a Class I recall for a fecal containment kit because it is not approved and has been linked to 13 severe adverse events, including one death, between February 2013 and March 2014.
The recall involves the Flexi-Seal CONTROL Fecal Management System Kit, manufactured by ConvaTec. The company did not seek legal clearance to market the device thorough the FDA 510(k) approval process.
The product is used to contain fecal matter from immobilized, incontinent patients with liquid or semi-liquid stool. The kit contains a soft catheter that is inserted into the rectum to divert waste. It is supposed to protect a patient’s wounds from fecal contamination, prevent infection, and keep bedding clean.
According to the recall notification:
“Use of this device may lead to: 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, and raw, irritated lesions due to skin contact with fecal matter; and death.”
The FDA has identified several problems that can result in patient injury or death, including:
- Auto-valve fails to limit inflation to 45mL
- Balloon is unable to be inflated fully
- Balloon is unable to be deflated fully
- Auto-valve leaks at Inflation Port
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