Permacol P100055Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884523000047), received between Sep 15, 2017 and Apr 13, 2021 — classified as 3 injuries, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED RE-DO NISSEN FUNDOPLICATION AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 11655669 ↗
• InjuryJan 5, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A PARAESOPHAGEAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11116676 ↗
• InjuryFeb 14, 2019Adverse 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 LARGE CYSTOCELE, RECTOCELE, ENTEROCELE, VAGINAL APEX PROLAPSE. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Injury

  MAUDE report 8340711 ↗
• MalfunctionSep 15, 2017Adverse 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE ABSCESS, ADHESIONS AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, LYSIS OF ADHESIONS AND IMPLANTATION OF NEW MESH. THE DEVICE HAD BEEN USED WITH CONCOMITANTLY WITH A PERFIX 4.1 X 4.8 CM MESH FOR REPAIR OF A RIGHT INGUINAL HERNIA. ON (B)(4) 2014 - REVISION, RECURRENT INCISIONAL HERNIA REPAIRED WITH STRATTICE 10 X 10 CM MESH. ON (B)(4) 2018 ¿ REVISION WITH STRATTICE 20 X 30 CM STRATTICE 10 X 16 CM.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Atrial Fibrillation; Discharge; Discomfort; Hernia; Hypoxia; Injury; Nausea; No Code Available; Obstruction/Occlusion; Scarring; Unspecified Infection; Vomiting

  MAUDE report 6868510 ↗