COLLAMEND 1175112Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741010569), received between Nov 28, 2018 and Nov 28, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED VIA (B)(6): THE PATIENT WAS IMPLANTED WITH COLLAMEND FM IN A PROCEDURE PERFORMED ON (B)(6) 2014. THE CONTACT ALLEGES, "THE DEVICE IS TOO TIGHT MY BOWEL HAS KNITTED INTO THE DEVICE AND AS A RESULT MY BOWEL IS INCAPABLE OF FUNCTIONING". "STARTED WITH A RECTOCELE, WAS LEFT WITH A HOLE IN THE BOWEL POST SURGERY, AS SURGERY WAS OPEN SURGERY HAD CONTENTS LEAKING FROM MY BOWEL INTO ABDOMEN, WAS LEFT WITH A GAPPING, GROWING LARGE OPEN CAVITY IN MY ABDOMEN, MY NAVEL ROTTED AWAY IT TOOK 15 MONTHS TO CLOSE, DISTRICT NURSES FOR 9 MONTHS AND 4 MONTHS OF A NEGATIVE ENERGY WOUND THERAPY BOX SUCKING 300 ML OF PUSS FROM MY ABDOMEN AS A RESULT OF THE FAILURE OF THE DEVICE, I NOW HAVE ANOTHER RECTOCELE, AN INTUSSUSCEPTION, AN ENTEROCELE, AND A VERY LARGE ABDOMINAL HERNIA, AND HAVE BEEN TOLD IT CAN'T BE REMOVED, MY ONLY OPTION IS AN ILOSTOMY."

  Patient problems: Bowel Perforation; Impaired Healing; Prolapse

  MAUDE report 8110955 ↗