The U.S. Food and Drug Administration (FDA) posted a medical device safety alert concerning Flexi-Seal CONTROL Fecal Management System (FMS) Kit, manufactured by ConvaTec, with the following product details:
According to the FDA, the manufacturer received reports from U.S. healthcare facilities of 13 adverse events including twelve serious injuries and one death for the period February 2013 through March 2014. The Auto-Valve feature that is unique to the Flexi-Seal CONTROL FMS Kit has not consistently performed relative to the inflation and deflation of the device's retention balloon. The failure modes of the device include: 1) Auto-valve fails to limit inflation to 45mL, 2) Balloon is unable to be inflated fully, 3) Balloon is unable to be deflated fully, and 4) Auto-valve leaks at Inflation Port.
Possible health hazards 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, and raw, irritated lesions due to skin contact with fecal matter. Death may also occur. The manufacturer advises users to stop using and return the affected devices.
For details, please refer to the FDA websites
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 23 Jun 2014