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Permacol P100205Recalls & reported problems

Sofradim Production · Surgical Implant · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884523000078), received between Jun 19, 2020 and Jun 19, 2020 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Adhesion(s)1
  • Failure of Implant1
  • Hernia1
  • Injury1
  • Pain1
  • Scarring1

Recent adverse event reports

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

  • InjuryJun 19, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A PARAESOPHAGEAL HIATAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, PAIN, ADHESIONS, SCARRING, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, LEFT AND RIGHT SLIDING RECTUS MYOFASCIAL ADVANCEMENT FLAPS, HERNIA REPAIR WITH NEW MESH, LEFT AND RIGHT ADIPOCUTANEOUS SKIN FLAPS, ADJACENT TISSUE TRANSFER CLOSURE OF ABDOMINAL WALL DEFECT, LEFT AND RIGHT ADIPOCUTANEOUS SKIN FLAPS, AND REMOVAL OF MESH.

    Patient problems: Adhesion(s); Failure of Implant; Hernia; Injury; Pain; Scarring

    MAUDE report 10174105 ↗

Other Mesh, surgical devices

All Mesh, surgical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.