Permacol P100510Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884523000092), received between Jun 11, 2019 and May 16, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2024Adverse 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 AN INCARCERATED INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, INFLAMMATION, SCARRING, MESH COMPLICATION INJURIES. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Hernia; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 19332272 ↗
• InjurySep 16, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BULGING, TENDERNESS, HARD/NODULAR TUMOR MASS, SCAR TISSUE, LOSS OF DOMAIN, LOSS OF INTEGRITY OF ANTERIOR ABDOMEN, GANGRENE ON THE RIGHT SCROTUM, (B)(6), ABDOMINAL PAIN, PAIN, AND LIPOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, RESECTION HORIZONTALLY-ORIENTED UNSTABLE SCAR DEFORMITY/REDUNDANT EPIDERMIS/DERMIS/SUBCUTANEOUS TISSUE/FASCIA WITHIN THE RLQ OF ANTERIOR ABDOMINAL WALL MEASURING, HERNIA REPAIR WITH COMPONENTS SEPARATION RECTUS ABDOMINUS MUSCLE FLAPS BASED UPON THE INFERIOR EPIGASTRIC AND SUPERIOR EPIGASTRIC NEUROVASCULAR BUNDLES, TISSUE REARRANGEMENT, HERNIA SAC REMOVED, TRANSPOSITION OF THE RECTUS ABDOMINUS MUSCLE FLAP FOR RECONSTRUCTION OF FOURNIER¿S GANGRENE ON THE RIGHT SCROTUM, AND MEDICATION.

  Patient problems: Abdominal Distention; Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Discomfort; Hernia; Muscle Weakness/Atrophy; Necrosis; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 12481134 ↗
• 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, ABDOMINAL PAIN, AND NARROWING OF ESOPHAGEAL HIATUS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Unspecified Tissue Injury

  MAUDE report 12109125 ↗
• InjuryJul 9, 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 RECURRENCE, ADHESIONS, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Discomfort; Hernia; Injury; Pain

  MAUDE report 10253408 ↗
• InjuryJul 5, 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 AN PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABSCESS AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH.

  Patient problems: Abscess; Fistula; Injury; Purulent Discharge; Unspecified Infection

  MAUDE report 8765269 ↗
• InjuryJul 5, 2019Migration or Expulsion of Device; Product Quality Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Product Quality Problem; 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 RECURRENT INCISIONAL UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, A FISTULA, MESH MIGRATION, DRAINAGE OF CHRONIC SINUS TRACT, ADHESIONS, INCARCERATED AND STRANGULATED SMALL BOWEL, NECROTIC ABDOMINAL WOUND STATUS POST CLOSED LOOP OBSTRUCTION, BOWEL HAD A DUSKY APPEARANCE, SCAR TISSUE, ASCITES, ABDOMINAL WALL ABSCESS, CHRONIC WOUND WITH EXPOSED BOWEL, SMALL BOWEL OBSTRUCTION, TWISTING AND TORSION OF BOWEL, THICKENED AREA OF MESENTERY AND SMALL BOWEL IN JEJUNUM, MESH ON THE RIGHT SIDE WAS SHRUNKEN AND WRINKLED, NON-HEALING SURGICAL WOUND SEQUELA, PURULENT MATERIAL IN SINUS TRACT, INFLAMMATION, FOREIGN BODY REACTION, PERITONITIS, HEMORRHAGE, EDEMA, FIBROTIC HERNIA SAC, SEROSITIS, AND INFECTED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED UMBILICAL HERNIA REPAIR, REMOVAL OF UMBILICUS, WOUND CLOSURE, INCISIONAL HERNIAS REPAIRED WITH SUTURES, LYSIS OF ADHESIONS, RESECTION OF NECROTIC SMALL BOWEL, RELEASED OF BOWEL FROM HERNIA SAC, DEBRIDEMENT OF EXUDATE IN SUPERIOR PORTION OF WOUND, DEBRIDEMENT OF SKIN NECROSIS, SUBCUTANEOUS TIS

  Patient problems: Abscess; Adhesion(s); Ascites; Discharge; Edema; Fibrosis; Fistula; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Injury; Necrosis; No Code Available; Obstruction/Occlusion; Peritonitis; Purulent Discharge; Scar Tissue; Unspecified Infection

  MAUDE report 8764210 ↗
• InjuryJun 11, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND RECURRENCE REPAIR.

  Patient problems: Abdominal Distention; Adhesion(s); Constipation; Fistula; Fluid Discharge; Hematoma; Hernia; Impaired Healing; Inflammation; Injury; Obstruction/Occlusion; Pain; Perforation; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8688374 ↗