Device maker ConvaTec landed in the FDA’s cross hairs after the company recalled a device that the agency says never underwent regulatory review.
ConvaTec recalled all lots of its Flexi-Seal Control fecal management system, a new addition to the FlexiSeal line, which never received FDA clearance. The device, which is used to manage fecal incontinence, was associated with 12 serious injuries and 1 patient death over about 1 year, according to the FDA notice.
ConvaTec representatives did not immediately return requests for comment.
The FDA chided ConvaTec for marketing the device without seeking regulatory review, saying that the "auto-valve" feature that was introduced in this product was associated with defects.
"The Auto-Valve feature that is unique to the Flexi-Seal Control Fecal Management System Kit has not consistently performed relative to the inflation and deflation of the device’s retention balloon," according to the memo. "This feature is one of the reasons a 510(k) application should have been submitted."
A shoddy auto-valve and inconsistent retention balloon could result in rectal damage, leakage or expulsion of the device or fecal soiling, which puts the patient at further risk of skin deterioration and irritated lesions, the FDA said.
The affected devices were manufactured from January 2013 through April 2014, and distributed from February 2013 through April 2014. ConvaTec issued an urgent notice in April 2014, asking customers to stop using the device and to quarantine any inventory remaining in possession.