Permacol P151015Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10884523000160), received between Nov 16, 2017 and Sep 16, 2021 — classified as 1 death, 23 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (6 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• 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 12481098 ↗
• InjurySep 9, 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 IMPLANT, THE PATIENT EXPERIENCED AN OPEN WOUND, (B)(6), RECURRENCE, PROSTATIC CALCIFICATIONS, ATROPHY OF THE RIGHT-SIDED RECTUS MUSCLE OF THE ANTERIOR ABDOMINAL WALL, BULGING, SEROUS DISCHARGE, SEROMA, PAIN, WOUND INFECTION, DEHISCED SURGICAL WOUND, HEMATOMA, COUGHING, NIGHT SWEATS, ADHESIONS, LUMP, ABDOMINAL PAIN, TENDERNESS, HARD/NODULAR MASS, SCAR TISSUE, LOSS OF DOMAIN, LOSS OF INTEGRITY OF ANTERIOR ABDOMEN, GANGRENE ON THE RIGHT SCROTUM, AND LIPOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, INCISION/DRAINAGE OF WOUND, ANTIBIOTICS, WOUND VAC, EXCISION OF DEHISCED SURGICAL WOUND, EVACUATION HEMATOMA, RECONSTRUCTION RLQ, DEBRIDEMENT, RECONSTRUCTION BY ELEVATION AND TRANSPOSITION OF BILATERAL FASCIOCUTANEOUS ADVANCEMENT FLAPS, HERNIA REPAIR WITH NEW MESH, 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 INF

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Calcium Deposits/Calcification; Diaphoresis; Discomfort; Fluid Discharge; Hematoma; Hernia; Impaired Healing; Muscle Weakness/Atrophy; Necrosis; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 12449008 ↗
• InjuryMay 20, 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 INFECTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, INCISION AND DRAINAGE, DEBRIDEMENT, AND MESH REMOVAL SURGERY.

  Patient problems: Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11858330 ↗
• InjuryDec 11, 2020Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH CONTRACTION, BALLED UP, WADDED UP, MESH FLOATING FREE, RECURRENCE, FAILURE OF MESH, ADHESIONS, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 10991633 ↗
• InjuryDec 8, 2020Migration or Expulsion of Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Detachment of Device or Device Component; 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 THE ONLAY IMPLANT, THE PATIENT EXPERIENCED SEPARATION OF MATERIAL LAYERS, ADHESIONS, FISTULA, RECURRENCE, ABSCESS, FIBROADIPOSE TISSUE, GRANULATION TISSUE, FOREIGN BODY REACTION, INFLAMMATION, HEMORRHAGE, HISTIOCYTIC REACTION, PAIN, BULGE, LOOSE MESH, LACK OF INCORPORATION, DRAINAGE, SINUS TRACT, PURULENT MATERIAL, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION, REVISION SURGERY, REMOVAL OF MESH, REMOVAL OF SUTURE MATERIAL, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Fluid Discharge; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10971766 ↗
• InjuryDec 5, 2020Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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, ABSCESS, RECURRENCE, BOWEL OBSTRUCTION, DISCOMFORT, NAUSEA, DISTENTION, BULGE, ABDOMINAL WALL DEHISCENCE, MESH PULLED AWAY, ADHESIONS, AND DRAINAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, INCISION/DRAINAGE OF ABDOMINAL WOUND, REMOVAL OF MESH, INCISION/DRAINAGE OF ABSCESS, HERNIA REPAIR WITH NEW MESH, COMPONENT SEPARATION, EXTENDED HOSPITALIZATION, DRAINS PLACED, REMOVAL OF SUTURES, AND WOUND VAC.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Discomfort; Fluid Discharge; Hernia; Nausea; Obstruction/Occlusion; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 10951024 ↗
• InjuryOct 20, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH, ABSCESS, ADHESIONS, RECURRENCE, A GRANULOMATOUS TRACT, GRANULOMA, GROWTH OF BACTEROIDES PYOGENES, AND SINUS TRACTS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, INCISION/DRAINAGE OF ABDOMINAL WALL ABSCESS, REMOVAL OF SUTURES, AND PRIMARY REPAIR OF VENTRAL HERNIA DEFECT WITH SUTURES ONLY.

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Granuloma; Hernia; Injury; No Code Available; Unspecified Infection

  MAUDE report 10708702 ↗
• InjuryOct 20, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, FAILURE OF MESH, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Failure of Implant; Hernia; Injury; Pain

  MAUDE report 10705289 ↗
• InjuryAug 10, 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENT HERNIA DUE TO FAILURE OF THE MESH, ADHESIONS OF BOWEL TO THE FAILED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION SURGERY.

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

  MAUDE report 10388032 ↗
• InjuryJul 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 10247261 ↗
• InjuryJul 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, ADHESIONS, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR.

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

  MAUDE report 10244620 ↗
• InjuryMar 6, 2020Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A NON-HEALING SURGICAL ABDOMINAL WOUND. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT HERNIA DUE TO FAILURE OF THE MESH, ABSCESS AND MESH HAD "DISRUPTED SUPRIORIY." POST-OPERATIVE PATIENT TREATMENT INCLUDED INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS DUE TO FAILURE OF THE MESH, ABDOMINAL WALL DEBRIDEMENT DOWN TO MUSCLE AND MESH REMOVAL SURGERY.

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

  MAUDE report 9800162 ↗
• InjuryMar 4, 2020Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, DISCHARGE, MENTAL PAIN, PHYSICAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE DEVICE, AND FAILURE OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, LYSIS OF ADHESIONS, HERNIA REPAIR, AND WOUND VAC.

  Patient problems: Adhesion(s); Discharge; Emotional Changes; Fluid Discharge; Hematoma; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Injury; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9784912 ↗
• InjuryDec 19, 2019Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; 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 MENTAL PAIN, PHYSICAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE DEVICE, DEVICE FAILURE, ADHESIONS, RECURRENCE, ABSCESS, INFECTED SEROMA, SMALL BOWEL OBSTRUCTION, FLUID COLLECTION, SUTURE GRANULOMA, PURULENT DISCHARGE, SEVERE ABDOMINAL PAIN, ERYTHEMATOUS, AND PAINFUL LUMP NEAR PREVIOUS DRAIN SITE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EXPLANTATION, IMPLANTATION OF NEW MESH, DEBRIDEMENT OF WOUND, LYSIS OF ADHESIONS, BILATERAL EXTERNAL OBLIQUE FASCIAL RELEASES, COMPLEX TISSUE REARRANGEMENT, AND CT GUIDED ABDOMINAL DRAIN PLACEMENT FOR ABDOMINAL WALL SEROMA.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Emotional Changes; Erythema; Fluid Discharge; Granuloma; Hernia; Injury; No Code Available; Obstruction/Occlusion; Pain; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9494631 ↗
• DeathJul 31, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN OPEN ABDOMINAL WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED PLACEMENT OF WOUND VAC. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. IT HAS BEEN STATED THAT THE DEATH DUE TO OR IS A CONSEQUENCE OF MULTI-ORGAN SYSTEM FAILURE, LIVER FAILURE, PULMONARY HYPERTENSION, RENAL FAILURE OR INCARCERATED VENTRAL HERNIA. INFORMATION REGARDING THE DATE OF DEATH IS UNAVAILABLE.

  Patient problems: Death; Impaired Healing; Injury

  MAUDE report 8846147 ↗
• InjuryJul 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT HERNIA, ADHESIONS, DRAINAGE, INFECTION, SEROMA, FAILURE OF THE MESH, FEVER, NAUSEA, ULCERATION NOTED WITH GANGRENE, FOREIGN BODY GIANT CELL REACTION AND NECROSIS. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY LAPAROTOMY, ENTEROLYSIS, PARTIAL OMENTECTOMY, SMALL BOWEL SEROSAL REPAIR, SKIN CLOSURE BY LOCAL FLAP ADVANCEMENT, LYSIS OF ADHESIONS, ABDOMINOPLASTY, EXCISION OF PREVIOUS MESH, SURGICAL WOUND AND SEROMA DRAINAGE, AND PLACEMENT OF NEW LIFECELL STRATTICE MESH. RELEVANT TESTS/LABORATORY DATA (B)(6) 2011: PATHOLOGY REPORT NOTED FOREIGN BODY GIANT CELL REACTION.

  Patient problems: Adhesion(s); Discharge; Failure of Implant; Fever; Foreign Body Reaction; Gangrene; Hernia; Injury; Nausea; Necrosis; Seroma; Ulceration; Unspecified Infection

  MAUDE report 8747149 ↗
• InjuryJun 11, 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 INCISIONAL ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Fibrosis; Fluid Discharge; Hernia; Inflammation; Injury; Purulent Discharge; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8687966 ↗
• InjuryJun 11, 2019Degraded; Material Erosion; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; 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 INCISIONAL ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, SEVERE PAIN, INFECTED MESH, FISTULOUS OPENINGS, MESH POKING THROUGH ERODED SKIN, INTRAABDOMINAL COLLECTION OF FLUID, DISTENDED ABDOMEN, MESH STRETCHED AND ATTENUATED, PORTION OF BOWEL DETACHED RESULTING IN ISCHEMIA, AND MESH BUCKLED. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REPAIR OF HERNIA WITH MESH, LYSIS OF ADHESIONS, REPAIR OF SMALL BOWEL ENTEROTOMY, DRAINAGE AND DEBRIDEMENT, SMALL BOWEL RESECTION, MESH REMOVAL, MIDLINE MESH DIVIDED FOR ENTRY, PULSE PERITONEAL LAVAGE, AND ADJACENT TISSUE TRANSFER CLOSURE.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Ascites; Erosion; Fistula; Hernia; Injury; Ischemia; Pain; Unspecified Infection

  MAUDE report 8687110 ↗
• InjuryApr 18, 2019Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT INCARCERATED UPPER MIDLINE INCISIONAL HERNIA WHERE THE MESH MIGRATED THROUGH THE HERNIA DEFECT. POST-OPERATIVE TREATMENT INCLUDED RECURRENT INCARCERATED INCISIONAL HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Hernia; Injury; No Code Available

  MAUDE report 8527350 ↗
• InjuryApr 9, 2019Product Quality Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Product Quality Problem; Detachment of Device or Device Component; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, CHRONIC NON-HEALING DRAINING ABDOMINAL WOUND, DEEP SUBCUTANEOUS ABSCESS POCKETS WITH PURULENT FLUID, DRAIN CLOGGED UP AND POCKETED AT THIS MATERIAL IN THE SUBCUTANEOUS POSITION, WHITISH COLOR OF THE PORCINE MESH, SMALL FLAKES OF THE MESH COMING OFF, INFECTION, BULGE IN ABDOMEN, PAIN, NAUSEA, FISTULA, FLUID COLLECTION, ANDTIGHT ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS AND WOUND DEBRIDEMENT, PLACEMENT OF DRAINING TUBE, SUBCUTANEOUS TISSUE CLEANED, RECURRENT INCARCERATED INCISIONAL HERNIA REPAIR WITH MESH, AND EXCISION OF MESH.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Ascites; Cellulitis; Discharge; Fistula; Hernia; Impaired Healing; Injury; Nausea; No Code Available; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 8495189 ↗
• InjuryMar 20, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC INFECTION, ADHESIONS AND DRAINAGE OF SINUS TRACT. POST-OPERATIVE TREATMENT INCLUDED REVISION SURGERY AND EXCISION OF MESH.

  Patient problems: Adhesion(s); Discharge; Foreign Body Reaction; Injury; Unspecified Infection

  MAUDE report 8438596 ↗
• InjuryAug 20, 2018Adverse 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 BOWEL OBSTRUCTION, AN INCARCERATED INCISIONAL HERNIA CONTAINING SMALL BOWEL, CHRONIC PAIN, INFECTION, AND ADHESIONS BETWEEN THE BOWEL AND MESH. TREATMENT INCLUDED REMOVAL OF THE MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Injury; Obstruction/Occlusion; Pain; Unspecified Infection; Vomiting

  MAUDE report 7799780 ↗
• InjuryApr 3, 2018Adverse 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ABDOMINAL WALL INFECTION, PAIN, ADHESIONS, FISTULA, INFECTIONS, PUS, NECROSIS, CHRONIC ABDOMINAL WOUND WITH SKIN GRAFT, OPEN WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EXCISION OF MESH, ABDOMINAL WOUND WASHOUT, WOUND VAC PLACEMENT, DEBRIDEMENT, AND SKIN GRAFT.

  Patient problems: Adhesion(s); Fistula; Hernia; Impaired Healing; Injury; Necrosis; No Code Available; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 7393004 ↗
• InjuryNov 16, 2017Adverse 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR WITH MESH. THE PATIENT EXPERIENCED SURGICAL REVISION, INFECTION AND FISTULA.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Biliary Cirrhosis; Fistula; Hematoma; Hernia; Inflammation; Injury; No Code Available; Obstruction/Occlusion; Pain; Perforation; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 7038402 ↗