Permacol P151828Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10884523000191), received between Oct 5, 2017 and Jun 6, 2025 — classified as 26 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2025Adverse 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 UNINCORPORATED MESH, RECURRENCE, ADHESIONS, CALCIFICATION, FOREIGN BODY REACTION, DISFIGUREMENT, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, WOUND CLOSURE, WOUND VAC.

  Patient problems: Adhesion(s); Calcium Deposits/Calcification; Deformity/ Disfigurement; Emotional Changes; Foreign Body Reaction; Hernia; Hypersensitivity/Allergic reaction; Pain; Unspecified Tissue Injury

  MAUDE report 22159167 ↗
• InjuryJun 14, 2023Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SINUS TRACT, ABDOMINAL WALL MASS, VASCULAR CONGESTION, SEROUS DRAINAGE,NON-HEALING WOUND, PURULENT DISCHARGE, ABDOMINAL PAIN, ADHESIONS, INFECTION, FISTULA, MASS, TENDERNESS, ERYTHEMA, SEROMA, HEMATOMA, SWELLING, ABSCESS, FOREIGN BODY REACTION, FIBROSIS, INFLAMMATION, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIALREMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, MEDICATION, HOSPITALIZATION, DEBRIDEMENT OF ANTERIOR ABDOMINAL WALL SINUS TRACT, PLACEMENT OF WOUND VAC, LYSIS OF ADHESIONS, SEGMENTAL ENTERECTOMY WITH ANASTOMOSIS, REMOVAL OF TACKS, PLACEMENT OF DRAINS, INCISION/DRAINAGE OF ABSCESS.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Erythema; Fibrosis; Fistula; Fluid Discharge; Foreign Body Reaction; Hematoma; Hernia; Impaired Healing; Inflammation; Nodule; Obstruction/Occlusion; Purulent Discharge; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Unspecified Vascular Problem

  MAUDE report 17127604 ↗
• InjuryOct 18, 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 THE IMPLANT, THE PATIENT EXPERIENCED ACUTE CHRONIC PAIN, INFECTION, DIGESTIVE PROBLEMS, DEPRESSION, SWELLING, BLOATING, SORENESS, LOSS ENJOYMENT OF LIFE, OBSTRUCTION, INFLAMMATION, SEROMA, ABSCESS RECURRENCE, OPEN WOUND, CHRONIC ULCERATED AREA ON LEFT LOWER ABDOMEN, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, MEDICATION, HOSPITALIZATION, MESH EXPLANT, WOUND VAC PLACEMENT, DRAIN PLACEMENT, HERNIA REPAIR WITH NEW MESH, AND ADHESIOLYSIS.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Depression; Discomfort; Emotional Changes; Hernia; Impaired Healing; Inflammation; Obstruction/Occlusion; Pain; Seroma; Swelling/ Edema; Ulcer; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12647503 ↗
• InjuryAug 13, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, SEGMENTAL PULMONARY EMBOLI, ATELECTASIS, SLOWLY IMPROVING TACHYCARDIA, DIARRHEA, PULMONARY INFARCTS, INFLAMMATION, AIR-FLUID COLLECTION, AND ILEUS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PICC LINE PLACED, NG TUBE, THERAPEUTIC ANTICOAGULATION FOR PE, IV HYDRATION, ANALGESICS, DRAIN IN PLACE, AND MESH REMOVAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Diarrhea; Distress; Inflammation; Pulmonary Embolism; Pulmonary Infarction; Tachycardia; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12321076 ↗
• InjuryJul 2, 2021Migration 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, RECURRENCE, ABDOMINAL SCAR WITH OPEN WOUND, MESH DETACHMENT, NECROSIS, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXCISION OF INFECTED MESH, OPEN PACKING OF ABDOMINAL WOUND, OPEN HERNIA REPAIR, SURGERY TO REMOVE PARTIAL MESH, REVISION SURGERY, AND DEBRIDEMENT OF ABDOMINAL WALL.

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

  MAUDE report 12109465 ↗
• InjuryMay 21, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABSCESS, FISTULA, INFECTION, AND PAIN. POST-OPERATIVE TREATMENT INCLUDED ADDITIONAL SURGERY, REVISION SURGERY, DEBRIDEMENT, AND MESH REMOVAL.

  Patient problems: Abscess; Fistula; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11867120 ↗
• InjuryMay 19, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABSCESS, FISTULA, INFECTION, AND PAIN. POST-OPERATIVE TREATMENT INCLUDED ADDITIONAL SURGERY, REVISION SURGERY, DEBRIDEMENT, AND MESH REMOVAL.

  Patient problems: Abscess; Fistula; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11851952 ↗
• InjuryMay 6, 2021Migration 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 BOWEL OBSTRUCTION, FAILURE OF MESH, MESH ROLLED ON ITSELF, ADHESIONS, LOSS OF DOMAIN, SCARRING, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY AND REMOVAL OF ADHESIONS.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11785614 ↗
• InjuryApr 26, 2021Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH INFECTION, PAIN, AND SOME OF THE MESH WAS FOUND FREE-FLOATING IN ABDOMEN. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC, ABDOMINAL WASHOUT, AND MESH REMOVAL SURGERY.

  Patient problems: Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11725460 ↗
• InjuryDec 14, 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, RECURRENCE, ABDOMINAL PAIN, AND DENSE ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, ABDOMINAL WALL COMPONENT SEPARATION MUSCLE FLAP ADVANCEMENT TECHNIQUE CLOSURE, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 11002466 ↗
• InjuryNov 25, 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 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 10906512 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction 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 ABSCESS, MESH FAILURE, INFECTION, FISTULA, AND ADHESIONS OF LIVER TO THE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, INCISION AND DRAINAGE OF ABSCESS, AND COLON AND MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Distress; Failure of Implant; Fistula; Hernia; Obstruction/Occlusion; Pain; Perforation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10885548 ↗
• InjurySep 22, 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 ADHESIONS AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 10565417 ↗
• InjuryAug 21, 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 THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SMALL BOWEL OBSTRUCTION, DISINTEGRATED MESH, PAIN, NAUSEA, LEUKOCYTOSIS, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Hernia; Injury; Nausea; No Code Available; Obstruction/Occlusion; Pain

  MAUDE report 10437260 ↗
• 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 THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Hernia; Injury; Unspecified Infection

  MAUDE report 10174017 ↗
• InjuryApr 15, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Degraded; 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED SEROMA, FAILURE OF MESH, INFECTION, AND FISTULIZING MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND VAC, AND NUMEROUS IRRIGATIONS AND DEBRIDEMENTS OF WOUND/INFECTION.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erythema; Failure of Implant; Fistula; Fluid Discharge; Granuloma; Impaired Healing; Inflammation; Injury; Necrosis; Obstruction/Occlusion; Pain; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9963554 ↗
• InjuryMar 26, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; 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 UNDERLAY IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFLAMMATION, BULGE, PAIN, HARD MESH, SCARRING, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, LYSIS OF ADHESIONS, REMOVAL OF MESH, AND ADMITTED TO HOSPITAL.

  Patient problems: Abdominal Distention; Adhesion(s); Hernia; Inflammation; Injury; Pain; Scarring

  MAUDE report 9882524 ↗
• InjuryNov 15, 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 RECURRENCE, PAIN, DISCOMFORT, DENSE ADHESIONS, AND A POCKET BETWEEN MESH AND THE ABDOMINAL WALL WITHOUT ANY EVIDENCE OF INTEGRATION OF THE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED OPEN VENTRAL HERNIA REPAIR WITH EXTENSIVE LYSIS OF ADHESIONS, ABDOMINAL WALL RECONSTRUCTION WITH UNDERLAY OF BIOLOGIC MESH USING STRATUS MESH, AND REPAIR OF RECURRENT INCISIONAL HERNIA.

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

  MAUDE report 9327904 ↗
• InjuryNov 15, 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 ABDOMINAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, ADHESIONS, HERNIA RECURRENCE, ABSCESS, SEROMA, SMALL BOWEL ADHERENCE, SMALL BOWEL SEROSAL TEARS, INFLAMMATION, FLUID COLLECTION, SMALL BOWEL WALL THICKENING, MARGINAL ULCER, ABDOMINAL PAIN, BULGING, NECROSIS, NAUSEA, VOMITING, AND CONSTIPATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, PANNICULECTOMY, REMOVAL AND ABSCESS DRAINAGE.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Ascites; Constipation; Hernia; Inflammation; Injury; Nausea; Necrosis; No Code Available; Pain; Seroma; Ulcer; Unspecified Tissue Injury; Vomiting

  MAUDE report 9325841 ↗
• InjurySep 19, 2019Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; 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 SMALL BOWEL OBSTRUCTION DUE TO FAILURE OF THE MESH, EROSION OF THE MESH INTO THE BOWEL AND ADHESIONS OF MESH TO BOWEL. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION SURGERY.

  Patient problems: Adhesion(s); Erosion; Failure of Implant; Injury; Obstruction/Occlusion

  MAUDE report 9094092 ↗
• InjuryJul 3, 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: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Hernia; Injury; No Code Available; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8761533 ↗
• InjuryJun 11, 2019Loss of or Failure to Bond; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. POST-OPERATIVE PATIENT TREATMENT INCLUDED MULTIPLE REVISIONS.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Fistula; Hernia; Impaired Healing; Inflammation; Injury; Nausea; No Code Available; Obstruction/Occlusion; Purulent Discharge; Respiratory Distress; Respiratory Insufficiency; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8686947 ↗
• InjuryDec 6, 2018Degraded; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; 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 CHRONIC WOUND INFECTION WITH INFECTED HERNIA MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY/MESH REMOVAL.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Discharge; Fistula; Fluid Discharge; Impaired Healing; Injury; Obstruction/Occlusion; Perforation; Purulent Discharge; Scar Tissue; Scarring; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8139527 ↗
• InjuryNov 15, 2017Adverse 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED AN ABSCESS, ADHESIONS, HEALING IMPAIRED, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL REVISION, ABSCESS IRRIGATION, WOUND VAC, SMALL BOWEL RESECTION WITH SIDE TO SIDE ANASTOMOSIS, AND EXTENSIVE LYSIS OF ADHESIONS.

  Patient problems: Abscess; Adhesion(s); Ascites; Impaired Healing; Injury; No Code Available; Pain; Scar Tissue

  MAUDE report 7034376 ↗
• InjuryOct 10, 2017Adverse 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT A LAPAROSCOPIC ATTEMPTED ROBOTIC REPAIR OF HERNIA, REPAIR OF INCARCERATED RECURRENT INCISIONAL HERNIA WITH MESH, SMALL BOWEL RESECTIONS X2, RIGHT AND LEFT COMPONENT SEPARATION OR RELEASING OF THE RECTUS ABDOMINAL MUSCLE AND ADVANCED, AND THE REMOVAL OF MESH. THE PATIENT EXPERIENCED PAIN.

  Patient problems: Injury; Pain

  MAUDE report 6934442 ↗