Permacol P152840Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884523000245), received between Jun 20, 2019 and Jan 3, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 3, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, ADHESIONS, OBSTRUCTION, FISTULA, MASS, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC, BOWEL RESECTION, LYSIS OF ADHESIONS, RESECTION OF ABDOMINAL MASS, REVISION SURGERY, MESH REVISION, LAPAROTOMY, AND MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Fluid Discharge; Impaired Healing; Necrosis; Nodule; Obstruction/Occlusion; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 16091464 ↗
• InjuryAug 26, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; 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 SEROMA, CHRONIC INFECTION DUE TO FAILURE OF MESH, ABSCESS, AND THE UNDERLAY OF THE MESH WAS IN PIECES. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC, WOUND DEBRIDEMENTS, REVISION SURGERY AND MESH REMOVAL.

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

  MAUDE report 12374703 ↗
• InjuryFeb 1, 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 RECURRENCE, FAILURE OF MESH, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION SURGERY.

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

  MAUDE report 11259754 ↗
• InjuryJan 6, 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 HERNIA. IT WAS REPORTED THAT AFTER THE UNDERLAY IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH. CONCOMITANT DEVICE: THORACAL TACKER.

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

  MAUDE report 11124583 ↗
• InjuryDec 12, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, OPEN WOUND, INFECTION, ABSCESS, ABDOMINAL PAIN, SURGICAL ULCERATION, NECROSIS, ASCITES, AND MULTIPLE LOCULES OF GAS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND DEBRIDEMENT OF WOUND.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Erythema; Hernia; Impaired Healing; Injury; Necrosis; No Code Available; Ulcer; Ulceration; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 9456899 ↗
• InjuryNov 19, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED NAUSEA, DIARRHEA, INFLAMMATION, ABDOMINAL STRENGTH LOSS, DISCOMFORT, INFECTION, NECROSIS, SINUS TRACT, LARGE SCAR, SEROMA/ABSCESS, CELLULITIS, EXTENSIVE BOWEL ADHESIONS TO MESH AND ONGOING, SEVERE PAIN, ABDOMINAL PAIN, MURKY DISCHARGE, IMPAIRED HEALING WOUND, ALLERGIC REACTION, FISTULA, SEROMA, PERFORATION, DEPRESSION, NUMBNESS, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Depression; Diarrhea; Discomfort; Fistula; Fluid Discharge; Hernia; Hypersensitivity/Allergic reaction; Impaired Healing; Inflammation; Injury; Muscle Weakness/Atrophy; Nausea; Necrosis; No Code Available; Numbness; Pain; Perforation; Purulent Discharge; Scar Tissue; Scarring; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9339890 ↗
• InjuryJun 20, 2019Material Erosion; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Erosion; 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 RECURRENT VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FISTULA, ENTEROCUTANEOUS FISTULA DRAINING FECULENT MATERIAL THROUGH SKIN, DENSE ADHESIONS, MESH THAT HAD ERODED INTO THE BOWEL, INFECTION, DENSE INFLAMMATORY TISSUE, AND SEROSAL TEAR. POST-OPERATIVE TREATMENT INCLUDED SMALL BOWEL RESECTION, WOUND VAC AND MULTIPLE REVISION SURGERIES.

  Patient problems: Adhesion(s); Discharge; Emotional Changes; Erosion; Excessive Tear Production; Fever; Fistula; Fluid Discharge; Hernia; Hypersensitivity/Allergic reaction; Impaired Healing; Inflammation; Injury; Pain; Perforation; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8716264 ↗