Permacol P101015Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10884523000115), received between Aug 28, 2013 and Nov 26, 2024 — classified as 43 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (10 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 43 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2024Migration 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 MESH DETACHMENT, PAIN, INFLAMMATION, ADHESIONS, OBSTRUCTION, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, MEDICATION, AND BOWEL RESECTION.

  Patient problems: Abdominal Pain; Adhesion(s); Inflammation; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 20788071 ↗
• InjuryMar 23, 2023Adverse 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ACUTE CHRONIC PAIN, INFECTION, HERNIA RECURRENCE, HEMATOMA, INFLAMMATION, ALLERGIC REACTION, ADHESIONS, OBSTRUCTIONS, BLEEDING, FISTULAS, SEROMA, PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REPAIR OF SMALL BOWEL FISTULA WITH PRIMARY REPAIR OF VENTRAL HERNIA, BOWEL REMOVAL, MESH REMOVAL, COLOSTOMY BAG PLACEMENT, MEDICATION, PREVIOUS BIOLOGIC MESH WAS NOTED AND INCISED.

  Patient problems: Adhesion(s); Fistula; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Obstruction/Occlusion; Pain; Perforation; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16600951 ↗
• InjuryDec 29, 2022Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED OBSTRUCTION, SEROMA, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, FAILURE OF MESH, RECURRENCE, INFLAMMATION, INFECTION, SCARRING, DEFECTIVE MESH, AND NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY LAPAROTOMY, REVISION SURGERY, SMALL BOWEL RESECTION, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Emotional Changes; Hernia; Inflammation; Nerve Damage; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16069830 ↗
• InjurySep 9, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction 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 IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, CONSTIPATION, NAUSEA, VOMITING, SPLIT MESH, CHRONIC ABDOMINAL WOUND, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LAPAROSCOPIC LYSIS OF ADHESIONS, DIAGNOSTIC LAPAROSCOPY, WOUND VAC, PRIMARY REPAIR OF HERNIA, AND HERNIA REPAIR WITH MESH.

  Patient problems: Adhesion(s); Constipation; Erosion; Hernia; Impaired Healing; Nausea; Obstruction/Occlusion; Pain; Unspecified Tissue Injury; Vomiting

  MAUDE report 12450884 ↗
• InjuryJul 15, 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 HERNIA RECURRENCE, THE FAILED MESH HAD RETRACTED AWAY FROM THE INCISION, 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 12177523 ↗
• InjuryMay 14, 2021Adverse 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, HEMATOMA, PERFORATION, NAUSEA, VOMITING, ALLERGIC REACTION, ABDOMINAL BLOATING, BULGING RECURRENT HERNIA, RECURRENCE, ADHESIONS, SCARRING, SEROMA, ABDOMINAL PAIN, ABDOMINAL WALL BURSA, INFLAMMATION, AND FOREIGN BODY GIANT CELL REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REVISION SURGERY, INCISION AND DRAINAGE, ABDOMINAL WALL RECONSTRUCTION, EVACUATION AND DEBRIDEMENT, PARTIAL EXPLANT SURGERY, RESECTION OF ABDOMINAL WALL BURSA WITH QUILTING PROGRESSIVE TENSION SUTURE RECONSTRUCTION ABLATION, REMOVAL OF MESH AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Erythema; Fever; Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nausea; Pain; Perforation; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 11828703 ↗
• InjuryMay 7, 2021Degraded; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Degraded; Migration or Expulsion of Device; Mechanics Altered; 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH, ADHESIONS, FAILED MESH, RECURRENCE, PAIN, PURULENT DRAINING CAVITY, FOLDED MESH, CALCIFIED MESH, AND MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL SURGERY, CUTTING INSTRUMENTS TO GET THROUGH ABDOMINAL WALL DUE TO CALCIFIED MESH, PLACEMENT OF WOUND VAC, HERNIA REPAIR WITH MESH, AND WOUND DEBRIDEMENTS.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Distress; Emotional Changes; Erosion; Failure of Implant; Fever; Hernia; Inflammation; Nausea; Pain; Perforation; Purulent Discharge; Scar Tissue; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 11794844 ↗
• InjuryJan 6, 2021Adverse 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 THE IMPLANT, THE PATIENT EXPERIENCED REDNESS, SWELLING, AND AN ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED INCISION/DRAINAGE OF ABSCESS.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erythema; Fistula; Hernia; Inflammation; Pain; Perforation; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11123839 ↗
• InjuryDec 28, 2020Migration or Expulsion of Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, SEPARATION OF MATERIAL LAYERS, MESH SEPARATION, ADHESIONS, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 11083584 ↗
• InjuryDec 9, 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, ABDOMINAL WALL NECROSIS, WOUND DEHISCENCE, RECURRENCE, DEAD SKIN, MESH SEPARATED FROM ABDOMINAL WALL, PURULENT MATERIAL, CELLULITIS, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL CLOSURE WITH PLACEMENT OF WOUND VAC, ROTATIONAL FLAPS OF LEFT/RIGHT ABDOMINAL WALL, EXTENDED HOSPITALIZATION, REMOVAL OF MESH, PARTIAL CLOSURE OF ABDOMINAL WOUND, ADMISSION TO HOSPITAL, DEBRIDEMENT OF NECROSIS, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Cellulitis; Hernia; Necrosis; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 10977667 ↗
• InjuryDec 2, 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 PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND SMALL BOWEL RESECTIONS.

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

  MAUDE report 10936874 ↗
• InjuryJul 24, 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 INFECTED SEROMA, WOUND INFECTION, NON-HEALING WOUND AND PURULENT/SEROSANGINOUS DRAINAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Impaired Healing; Injury; Purulent Discharge; Seroma; Unspecified Infection

  MAUDE report 10319891 ↗
• InjuryJul 21, 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, RECURRENCE, ABSCESS AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Hernia; Injury; Pain; Unspecified Infection

  MAUDE report 10301728 ↗
• InjuryJul 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, NAUSEA, VOMITING, RECURRENCE, AND BOWEL OBSTRUCTION POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, HERNIA REPAIR WITH NEW MESH, REMOVAL OF SCREWS, AND MESH REMOVAL.

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

  MAUDE report 10273009 ↗
• 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 10251861 ↗
• InjuryJul 8, 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, HERNIA RECURRENCE, ABSCESS, INFECTION, BULGING, NAUSEA, VOMITING, ABDOMINAL PAIN, SWELLING, SEROMA, ERYTHEMA, TENDERNESS, FEVER, UTI, PURULENT MATERIAL, MESH POORLY INCORPORATED, INFECTION, EPIGASTRIC ARTERY WAS INJURED AND ADHESIONS. POST-OPERATIVE TREATMENT INCLUDED INCISION/DRAINAGE OF ABSCESS, MULTIPLE REVISION SURGERIES, HERNIA REPAIR WITH NEW MESH, REMOVAL OF OLD SUTURE MATERIAL, ADMISSION TO HOSPITAL, IR DRAINS REMOVED, DRAIN PLACED, ANTIBIOTICS, LYSIS OF ADHESIONS, MYOCUTANEOUS FLAP ON THE LEFT, EPIGASTRIC ARTERY WAS LIGATED, WOUND DRESSINGS, WOUND VAC AND MESH REMOVAL.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Discomfort; Erythema; Fever; Hernia; Injury; Nausea; Pain; Purulent Discharge; Seroma; Swelling; Unspecified Infection; Urinary Tract Infection; Vomiting

  MAUDE report 10245158 ↗
• InjuryJul 7, 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 RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH REVISION.

  Patient problems: Hernia; Injury; Unspecified Tissue Injury

  MAUDE report 10240379 ↗
• InjuryApr 30, 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 THE IMPLANT, THE PATIENT EXPERIENCED PAIN, SCARRING, MESH MIGRATION, SEXUALLY IMPAIRED, EMBARRASSMENT, LOOKS 9 MONTHS PREGNANT AND BULGING. POST-OPERATIVE PATIENT TREATMENT DEEMED THAT REVISION SURGERY WAS TOO DANGEROUS.

  Patient problems: Abdominal Distention; Injury; No Code Available; Pain; Scarring

  MAUDE report 10013826 ↗
• InjuryMar 27, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, FISTULA, INFLAMMATION, FAILURE OF MESH, AND EXPOSED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOULD EXPLORATION AND DEBRIDEMENT, MESH REMOVAL, AND WOUND VAC PLACEMENT.

  Patient problems: Failure of Implant; Fistula; Inflammation; Injury; Unspecified Infection

  MAUDE report 9888898 ↗
• InjuryMar 26, 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 INCISIONAL HERNIA. THE PATIENT EXPERIENCED RECURRENCE, INFLAMMATION, FOREIGN BODY CELLS, SCARRING, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PIECE OF MESH ON EDGE OF HERNIA INCISED, PARTIAL REMOVAL OF PRIOR MESH, RECURRENCE REPAIR AND LYSIS OF ADHESIONS.

  Patient problems: Adhesion(s); Foreign Body Reaction; Hernia; Inflammation; Injury; Pain; Scar Tissue; Scarring; Unspecified Tissue Injury

  MAUDE report 9883610 ↗
• InjuryMar 26, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BACTERIAL INFECTION, OPEN WOUND, ABDOMINAL FLUID, ABDOMINAL AIR, ABDOMINAL SKIN THICKENING, DIASTASIS, MESENTERIC FAT, METABOLIC ACIDOSIS, RESPIRATORY FAILURE, ILEUS, SEPSIS, BOWEL PERFORATION, ANEMIA, LOSS OF DOMAIN, FIBROSIS, PURULENT MATERIAL DRAINAGE, FECAL DRAINAGE, MESH NOT INCORPORATED, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION, INCIDENTAL APPENDECTOMY, ADMITTED TO HOSPITAL, IV FLUIDS, IV PRESSORS, ANTIBIOTICS, TPN, TRANSFUSION, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, MESH REMOVAL, AND SKIN GRAFT.

  Patient problems: Adhesion(s); Anemia; Ascites; Bacterial Infection; Bowel Perforation; Discharge; Fibrosis; Hernia; Impaired Healing; Injury; No Code Available; Obstruction/Occlusion; Purulent Discharge; Respiratory Failure; Sepsis

  MAUDE report 9883233 ↗
• InjuryMar 6, 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 NONHEALING ABDOMINAL WOUND AS WELL AS NECROTIC TISSUE IN AREA OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED IRRIGATION AND DEBRIDEMENT AS WELL AS MESH REMOVAL SURGERY.

  Patient problems: Impaired Healing; Injury; Necrosis

  MAUDE report 9800917 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION DUE TO FAILURE OF THE MESH, ABSCESS, SINUS TRACK DOWN TO THE MESH, FISTULA, DENSE ADHESIONS OF OMENTUM TO MESH, NECROSIS AND FOREIGN BODY GIANT CELL REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION REMOVAL SURGERY.

  Patient problems: Abscess; Adhesion(s); Failure of Implant; Fistula; Foreign Body Reaction; Hernia; Injury; Necrosis; No Code Available; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9738201 ↗
• InjuryJan 22, 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 PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED TACHYCARDIC, HYPOTENSIVE, DECREASE IN HEMATOCRIT, ADHESIONS, CLOT, HOSTILE ABDOMEN, RECURRENCE, MESH FAILURE, SEROSAL TEAR, FISTULAS, PERFORATIONS, ABDOMINAL PAIN, AND BLEEDING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, PARTIAL REMOVAL OF MESH, SEROSAL TEAR REPAIRED, ABDOMINAL WASHOUT, ABDOMINAL WALL CLOSURE, REMOVAL OF TACKS, RECEIVED SEVERAL UNITS OF BLOOD, ARTERIAL LINE PLACEMENT, LYSIS OF ADHESIONS, PRIMARY CLOSURE OF PARASTOMAL HERNIA MEDIALLY, BOWEL RESECTION, ILEOSTOMY, RELOCATION OF ILEOSTOMY, AND TAKEN TO SICU.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blood Loss; Failure of Implant; Fistula; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Injury; Low Blood Pressure/ Hypotension; No Code Available; Perforation; Tachycardia; Thrombosis/Thrombus; Thrombus; Unspecified Tissue Injury

  MAUDE report 9618145 ↗
• InjuryDec 6, 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 PAIN, INFECTION, ADHESIONS AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 9422400 ↗