Events

Safety Alert for Flexi-Seal CONTROL Fecal Management System Kit

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by ConvaTec.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-06-23
  • Event Date Posted
    2014-06-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140623.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: convatec flexi-seal control fecal management system kit 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: model no.: icc 411107 lot no.: all manufactured from january 2013 through april 2014 and distributed from february 13, 2013 through april 14, 2014. 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 http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm402137.Htm http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm402172.Htm 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.

Device

Flexi-Seal CONTROL Fecal Management System Kit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: ConvaTec Flexi-Seal CONTROL Fecal Management System Kit
  • Manufacturer
    ConvaTec

Manufacturer

ConvaTec