Permacol P151020Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884523000177), received between Mar 29, 2019 and May 4, 2023 — classified as 16 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2023Adverse 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16870889 ↗
• InjurySep 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 INFLAMMATION, INFECTION, OPEN DRAINING WOUND, SCARRING, ABDOMINAL PAIN, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Abscess; Fluid Discharge; Impaired Healing; Inflammation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12418630 ↗
• InjuryJul 15, 2021Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  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 RECURRENT HERNIA DUE TO FAILURE OF THE MESH, MESH MIGRATION AND TEARING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, HERNIA REPAIR WITH MESH, AND REVISION SURGERY.

  Patient problems: Failure of Implant; Hernia; Unspecified Tissue Injury

  MAUDE report 12178793 ↗
• InjuryMay 20, 2021Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Mechanics Altered; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENT DRAINAGE FROM MIDLINE WOUND, SMALL BOWEL ABSCESS, SEROSAL TEARS, INFECTION, DESMOPLASTIC REACTION, PURULENT MATERIAL, MIGRATED MESH, NON-HEALING WOUND, SCARRING, ABDOMINAL PAIN, RECURRENCE, ENTEROTOMY, MESH EROSION, AND NECROSIS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH SUTURES, RESECTION OF ABDOMINAL WALL WITH EXCISION OF UMBILICUS, REVISION OF MESH, REMOVAL OF MESH, DISSECTION OF ADHESIONS, REPAIR OF SEROSAL TEARS, DEBRIDEMENT OF NECROTIC TISSUE/NON-VIABLE SKIN, HERNIA REPAIR WITH NEW MESH, REPAIR OF SMALL BOWEL ENTEROTOMY, LYSIS OF ADHESIONS, EXCISION OF MESH, COMPONENT SEPARATION, WOUND CLOSURE OF MYOCUTANEOUS ADVANCEMENT FLAPS, AND DRAINAGE OF PURULENT MATERIAL.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Necrosis; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Ulcer; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11861142 ↗
• InjuryApr 1, 2021Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Mechanics Altered; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, MENTAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, LOSS OF CARE/COMFORT/CONSORTIUM, CHRONIC INFLAMMATION, BOWEL NECROSIS, FISTULA, EXTENSIVE BOWEL ADHESIONS, BOWEL EROSION, OPEN WOUND, ABDOMINAL PAIN, ENTEROTOMY, DEFECTIVE PARIETEX MESH, FAILURE OF PARIETEX MESH, BOWEL DESEROSALIZATION, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, BOWEL RESECTION, INVASIVE SURGERY, SURGERY TO REMOVE AND/OR EXCISE ALL OR PART OF THE DEFECTIVE PARIETEX MESH, AND WOUND VAC.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Calcium Deposits/Calcification; Cellulitis; Discomfort; Emotional Changes; Fibrosis; Fistula; Fluid Discharge; Granuloma; Hernia; Impaired Healing; Inflammation; Necrosis; Pain; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11602343 ↗
• InjuryMar 11, 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 AN INCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, ADHESIONS, RECURRENCE, AND PAIN.

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

  MAUDE report 11462103 ↗
• InjuryNov 26, 2020Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  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, CHRONIC PAIN, ADHESIONS, FISTULA, OPEN WOUND, SCARRING, DEHISCENCE, UNATTACHED MESH, AND BROKEN MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND WOUND VAC.

  Patient problems: Adhesion(s); Fistula; Hernia; Impaired Healing; Pain; Scar Tissue; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 10907396 ↗
• InjuryNov 23, 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 INFECTED SEROMA AND MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED INCISION AND DRAINAGE OF INFECTED SEROMA, MESH REMOVAL, REVISION SURGERY, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Failure of Implant; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10885488 ↗
• InjuryJul 9, 2020Adverse 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 SEVERE PAIN, ADHESIONS, INCARCERATED HERNIA, SEROSAL DEFECTS, DILATED LOOPS OF BOWEL, AND UNINCORPORATED MESH. POST-OPERATIVE TREATMENT INCLUDED REVISION SURGERY, SEROSAL DEFECTS REPAIRED, DECOMPRESSED BOWEL DISTALLY, LYSIS OF ADHESIONS, HERNIA REPAIR WITH NEW MESH, EXCISION OF HERNIA SAC, AND MESH REMOVAL.

  Patient problems: Adhesion(s); Hernia; Injury; Obstruction/Occlusion; Pain

  MAUDE report 10254388 ↗
• InjuryApr 8, 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 BILATERAL SPIGELIAN HERNIAS. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, SINUS TRACT, PURULENT MATERIAL, GRANULOMA, ADHESIONS, FLUID COLLECTION, ABSCESS, MRSA, PAIN, NAUSEA, PARTIAL OBSTRUCTIVE SYMPTOMS, AND MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EXCISIONAL DEBRIDEMENT OF SURGICAL SITE INFECTION, REMOVAL OF SUTURES, WOUND DEBRIDEMENT, WOUND VAC/DRESSINGS, HERNIA REPAIR WITH MESH, SMALL BOWEL RESECTION, RESECTION OF SKIN AND SUBCUTANEOUS TISSUE, RIGHT AND LEFT MYOFASCIAL ADVANCEMENT FLAPS, INCISIONAL DRAINAGE OF ABSCESS, COMPLEX LAYERED CLOSURE OF ABDOMEN, EXCISION OF SINUS TRACT, AND REMOVAL OF MESH.

  Patient problems: Abscess; Adhesion(s); Ascites; Failure of Implant; Granuloma; Hernia; Injury; Nausea; No Code Available; Obstruction/Occlusion; Pain; Purulent Discharge; Staphylococcus Aureus; Unspecified Infection

  MAUDE report 9940950 ↗
• InjuryOct 7, 2019Material Erosion; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Erosion; Migration or Expulsion of Device; 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 INCARCERATED ABDOMINAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER UNDERLAY IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN, HERNIA RECURRENCE, INFLAMMATION, MESHOMA, INFECTION, DENSE ADHESIONS, ENTEROCUTANEOUS FISTULA, SCARRING, ABDOMINAL WALL CELLULITIS, DRAINING SINUS, NECROTIC TISSUE, AND MESH ERODING INTO SMALL BOWEL. POST-OPERATIVE PATIENT TREATMENT INCLUDED DEBRIDEMENT AND REMOVAL SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Depression; Discharge; Emotional Changes; Erosion; Fistula; Fluid Discharge; Hernia; Inflammation; Injury; Necrosis; No Code Available; Nodule; Pain; Scar Tissue; Scarring; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9164420 ↗
• InjuryOct 1, 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 A RECURRENT VENTRAL HERNIA. IT WAS REPORTED THAT AFTER ONLAY IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Injury

  MAUDE report 9138079 ↗
• InjurySep 26, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Injury

  MAUDE report 9126911 ↗
• InjurySep 17, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE AND LOSS OF TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Injury; No Code Available; Obstruction/Occlusion; Pain; Perforation; Unspecified Tissue Injury

  MAUDE report 9074340 ↗
• InjuryMay 7, 2019Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loss of or Failure to Bond; 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 IMPLANT, THE PATIENT EXPERIENCED INFECTION, ABSCESS, LACK OF INCORPORATION, DRAINAGE OF PURULENT MATERIAL, FISTULA, OPEN WOUND. POST-OPERATIVE TREATMENT INCLUDED REVISION SURGERY, MESH COMPLETELY EXCISED, AND WOUND VAC.

  Patient problems: Abscess; Fistula; Impaired Healing; Injury; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8588209 ↗
• InjuryMar 29, 2019Material Perforation; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Perforation; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FISTULA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY SMALL BOWEL RESECTION, ANASTOMOSIS OF LONGSTANDING ENTEROCUTANEOUS FISTULA AND EXCISION OF PREVIOUS MESH WITH PLACEMENT OF NEW MESH.

  Patient problems: Abscess; Adhesion(s); Bowel Perforation; Fistula; Foreign Body Reaction; Hernia; Impaired Healing; Inflammation; Injury; No Code Available; Pain; Perforation; Sepsis; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8465213 ↗