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Flexi-Seal Control FMS

Flexi-Seal CONTROL Linked to Serious Injury and Death

Thomas J. Henry is currently investigating reports of serious injury and death in connection with the Flexi-Seal CONTROL Fecal Management System.

Recent safety alerts by the U.S. Food and Drug Administration (FDA) indicate that a defective valve in the device can result in expulsion of the device, rectal damage, necrosis, and death.

The regulatory authority further alleges that ConvaTec, the manufacturer of the Flexi-Seal CONTROL, failed to submit the device for regulatory review before marketing and distributing the defective product to health care facilities.

13 REPORTS OF SERIOUS INJURY AND DEATH

Over a period of a year, the FDA has noted 13 adverse event reports in which use of the Flexi-Seal CONTROL Fecal Management System has resulted in serious injury or death.

Adverse event cited by the FDA include:

  • Necrosis
  • Perforation
  • Ulceration
  • Peeling Skin
  • Rectal Damage
  • Death

FLEXI-SEAL CONTROL NEVER SUBMITTED FOR REGULATORY REVIEW

According to the FDA, ConvaTec began marketing and distribution of the device without seeking regulatory review.

Although the company manufactured similar devices in the past, the recalled Flexi-Seal CONTROL Fecal Management System was significantly different from the previous versions, and would have needed a 510(k) application submission to be considered for approval by the FDA.

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