Permacol P152040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884523000214), received between Apr 5, 2018 and Feb 21, 2020 — classified as 2 injuries.

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.

• InjuryFeb 21, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABSCESS DUE TO FAILURE OF MESH, MESH HAD NECROTIZED, CAUSING INFECTION AND HEMATOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED DEBRIDEMENT OF ABDOMINAL WALL AND REVISION SURGERY.

  Patient problems: Abscess; Failure of Implant; Hematoma; Injury; Necrosis; Unspecified Infection

  MAUDE report 9738273 ↗
• InjuryApr 5, 2018Adverse 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT A VENTRAL HERNIA REPAIR WITH MESH BILATERAL RECTUS ADVANCEMENT FLAPS. REVISION SURGERY 5 YEARS AND 9 MONTHS POST-SURGERY. THE PATIENT EXPERIENCED SURGICAL REVISION, RECURRENCE , PAIN.

  Patient problems: Hernia; Injury; No Code Available; Pain

  MAUDE report 7399321 ↗