The U.S. Food and Drug Administration (FDA) is reviewing ConvaTec following the recall of a medical device that the FDA claims never underwent regulatory review. The defective device has been linked to multiple adverse event including serious injury and death.
According to MassDevice, ConvaTec has issued a recall for all lots of its Flexi-Seal CONTROL Fecal Management System following 12 reports of serious injury and one report of patient death over a period of roughly 12 months.
The device is a new addition to the company’s Flexi-Seal line and is used in health care facilities to manage fecal incontinence. The device collects liquid and semi-liquid stool and also provides a means to administer medication.
The Flexi-Seal CONTROL introduced an automatic valve that shuts off filling of the retention balloon as soon as optimal volume is reached; however, according to the recall, it is this automatic valve that is at the center of the recall.
The recall states that a defect in valve could result in leakage, expulsion of the device, fecal soiling, rectal damage, and death.
In response to the adverse event reports, the FDA has issued a safety alert in which it designates the Flexi-Seal CONTROL recall as a Class 1 recall, meaning that there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
Further complicating the matter are allegations by the FDA that ConvaTec marketed the Flexi-Seal CONTROL Fecal Management System without ever submitting the device for regulatory review. Had such a review been completed, it is likely that the defective valve would have been detected, preventing the series of adverse events.
Affected devices were manufactured between January 2013 and April 2014 and distributed between February 2013 and April 2014.
Customers are urged to discontinue use with the recalled devices, and health care facilities and distributors have been told to quarantine any remaining inventory.