Permacol P152050Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884523000221), received between Mar 12, 2019 and Oct 9, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, OBSTRUCTION, ADHESIONS, PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion; Pain; Perforation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20408670 ↗
• InjuryNov 18, 2020Adverse 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 MIDLINE INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, BOWEL RESECTION, AND PARTIAL REMOVAL OF MESH.

  Patient problems: Adhesion(s); Hernia; Unspecified Tissue Injury

  MAUDE report 10862132 ↗
• InjuryMay 12, 2020Migration 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND SEPARATION OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY. CONCOMITANT DEVICE: SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL (PRODUCT ID: 12BSGUSS60G, LOT NO: 06538579).

  Patient problems: Hernia; Injury

  MAUDE report 10048362 ↗
• InjuryJul 5, 2019Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction 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 PERFORATION, OBSTRUCTION, PAIN, INTESTINAL ADHESIONS TO THE MESH, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, LYSIS OF ADHESIONS, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Fever; Fistula; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Injury; Obstruction/Occlusion; Pain; Perforation; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8764162 ↗
• InjuryApr 18, 2019Loss of or Failure to Bond; Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Migration or Expulsion of Device; Material Integrity 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/INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT HERNIA, ABDOMINAL WOUND DEHISCENCE, ADHESIONS, NON-HEALING WOUND, EXPOSED BOWEL, GRANULATING BOWEL, CONTRACTION OF MESH, DISCOMFORT, OMENTAL AND ABDOMINAL WOUND INFECTION, PERIMETER OF PERMACOL INTACT WITH CENTRAL LOSS EVIDENT, DRAINAGE FROM MIDLINE ABDOMINAL WOUND, ABSCESS, FIBROUS EXUDATE, NECROSIS, SMALL BOWEL OBSTRUCTION, PURULENT FLUID. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, RECURRENT HERNIA REPAIR WITH MESH, REMOVAL OF FIBROUS EXUDATE OR OTHER NECROTIC TISSUE FROM THE WOUND SURFACES, ABSCESS DRAIN PLACEMENT, REPAIR USING SKIN GRAFT, SMALL BOWEL RESECTION, REMOVAL OF MESH, INCISION AND DRAINAGE OF WOUND, WOUND VAC, AND DRAIN PLACED.

  Patient problems: Abscess; Adhesion(s); Discharge; Discomfort; Hernia; Impaired Healing; Injury; Necrosis; No Code Available; Obstruction/Occlusion; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 8528190 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER AN OPEN ABDOMINAL WALL REPAIR USING THE BRIDGE OPERATIVE APPROACH, THE SURGEON SAID THE MESH APPEARED FINE, BUT DUE TO A SMALL BOWEL FISTULA, THEY DECIDED TO REMOVE THE DEVICE TO PREVENT INFECTION. IT WAS NOTED THAT THE WOUND WAS NOT CLOSED AND A WOUND VACUUM-ASSISTED CLOSURE WAS PLACED OVER IT.

  Patient problems: Fistula

  MAUDE report 8412169 ↗