Permacol P151010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884523000153), received between Mar 5, 2021 and Jul 2, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE UNDERLAY IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 12112377 ↗
• InjuryMar 5, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, EXPOSED BOWEL, MESH PULLED BACK/AWAY, WOUND DEHISCENCE, NECROSIS, AND FISTULA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ADMISSION/HOSPITALIZATION, PLACEMENT OF MESH, LOOP COLOSTOMY, LYSIS OF ADHESIONS, TAKEDOWN COLOSTOMY, SEGMENTAL COLOSTOMY, COLOCOLOSTOMY, COMPONENT SEPARATION, AND PLACEMENT OF DRAIN, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Fistula; Hernia; Necrosis; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11422357 ↗