Permacol P101520Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10884523000122), received between Oct 24, 2018 and Oct 25, 2021 — classified as 29 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 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 IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Unspecified Tissue Injury

  MAUDE report 12687176 ↗
• 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, OBSTRUCTION, OPEN WOUND, CELLULITIS, DRAINAGE, GR ANULOMATOUS FIBRINOUS EXUDATE, INFECTION, ADHESIONS, LOSS OF DOMAIN, LEUKOCYTOSIS, ABDOMINAL PAIN, TENDERNESS, SCAR TISSUE, ELEVATED LACTATE LEVEL, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, REVISION SURGERY, LYSIS OF AD HESIONS, ADMISSION TO HOSPITAL, DRAIN PLACEMENT, ICU, MEDICATION, AND WOUND VAC PLACEMENT. RELEVANT TESTS/LABORATORY DATA: 21 MAY 2011: OP NOTE STATED LEUKOCYTOSIS AND ELEVATED LACTATE LEVEL

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

  MAUDE report 11855555 ↗
• 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 11792661 ↗
• InjuryApr 8, 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 ADHESIONS, PAIN, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH.

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

  MAUDE report 11636042 ↗
• InjuryMar 8, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, MUSCLE SPASMS, MESH SEPARATION, MESH DETACHMENT, RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Adhesion(s); Cramp(s) /Muscle Spasm(s); Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 11434961 ↗
• 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 11081028 ↗
• 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 10976763 ↗
• InjuryNov 18, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED NECROSIS, MESH DETACHMENT, AND OPEN DRAINING WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Fluid Discharge; Impaired Healing; Necrosis; Unspecified Tissue Injury

  MAUDE report 10860403 ↗
• 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 10569316 ↗
• InjuryAug 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESION, PAIN, RECURRENCE, SCARRING, INFLAMMATION, AND GIANT CELL REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 10463209 ↗
• InjuryAug 11, 2020Degraded; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Degraded; 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 THE IMPLANT, THE PATIENT EXPERIENCED SUBCUTANEOUS INFECTION DUE TO FAILURE OF THE MESH, PAIN, THE MESH HAD COMPLETELY DETERIORATED AND WAS NO LONGER IN PLACE, WAS FREE-FLOATING AND ABDOMINAL ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED PLACEMENT OF WOUND VAC, IRRIGATION AND DEBRIDEMENT AND MESH REVISION SURGERY.

  Patient problems: Abscess; Failure of Implant; Injury; Pain; Unspecified Infection

  MAUDE report 10391092 ↗
• InjuryAug 7, 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, ADHESIONS, FISTULA, ULCERATED HERNIA SAC, INFLAMMATION, FIBROSIS, DEVASCULARIZED HERNIA SAC., WOUND OPENING, WOUND DEHISCENCE, SMALL BOWEL EVISCERATION, EXPOSED INTESTINE, GUT FAILURE, CALCIFICATION, SCAR TISSUE, ULCERS, AND MESH EROSION INTO VISCERA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, EVISCERATION, TAKEDOWN/REPAIR OF GASTROCUTANEOUS FISTULA, REPAIR OF ENTEROTOMY OF THE COLONIC CONDUIT, PRIMARY REPAIR OF ENTEROTOMY OF THE COLON, EXCISED SKIN/SUBCUTANEOUS TISSUE, RIGHT/LEFT MYOFASCIAL ADVANCEMENT FLAP, CLOSURE OF FASCIA, WOUND VAC, PRIMARY SKIN CLOSURE, FULL-THICKNESS BIOPSY OF THE DEEP ABDOMINAL WALL ULCERS, CLOSURE OF ABDOMEN IN 2 LAYERS, AND CHOLECYSTECTOMY.

  Patient problems: Adhesion(s); Calcium Deposits/Calcification; Erosion; Fibrosis; Fistula; Hernia; Impaired Healing; Inflammation; Injury; No Code Available; Scar Tissue; Ulcer; Ulceration; Wound Dehiscence

  MAUDE report 10379880 ↗
• InjuryJul 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 CHRONIC PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY.

  Patient problems: Hernia; Injury; Pain

  MAUDE report 10310970 ↗
• 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 THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS AND BOWEL OBSTRUCTION POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

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

  MAUDE report 10273104 ↗
• InjuryJun 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, AND REMOVAL OF MESH.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 10201512 ↗
• InjuryJan 3, 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, INFECTED MESH AND BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Failure of Implant; Granuloma; Hernia; Impaired Healing; Injury; Obstruction/Occlusion; Scarring; Unspecified Infection

  MAUDE report 9543402 ↗
• InjuryJan 2, 2020Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 INFECTED VENTRAL HERNIA. IT WAS REPORTED THAT AFTER UNDERLAY IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN, HERNIA RECURRENCE, ADHESIONS, INFECTION, UNINCORPORATED MESH AND SMALL BOWEL OBSTRUCTION WITH STRANGULATED BOWEL. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Cellulitis; Cramp(s) /Muscle Spasm(s); Depression; Discomfort; Erythema; Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Injury; Itching Sensation; Muscle Weakness/Atrophy; Nausea; Obstruction/Occlusion; Pain; Perforation; Respiratory Failure; Seroma; Sleep Dysfunction; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 9538880 ↗
• 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 ABDOMINAL WALL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BULGE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 9140441 ↗
• InjurySep 26, 2019Adverse 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 RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Aspiration Pneumonitis; Aspiration/Inhalation; Bacterial Infection; Cyst(s); Deformity/ Disfigurement; Emotional Changes; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Injury; Nausea; Obstruction/Occlusion; Pain; Purulent Discharge; Renal Failure; Respiratory Failure; Sepsis; Seroma; Stenosis; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 9121985 ↗
• InjuryAug 11, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH MIGRATION, PAIN AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXCISION SURGERY.

  Patient problems: Hernia; Injury; Pain; Unspecified Infection

  MAUDE report 8881874 ↗
• InjuryJul 8, 2019Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABSCESS, RECURRENCE, HEMATOMA, EXTENSIVE DENSE ADHESIONS, MESH EROSION INTO VISCERA, MESH MIGRATION AND SEROSAL TEAR, AND ABDOMINAL MASS. POST-OPERATIVE PATIENT TREATMENT INCLUDED DRAINAGE OF HEMATOMA, TAKEDOWN OF ADHESIONS, SEROSAL TEAR REPAIR, INCISIONAL HERNIA RECURRENCE REPAIR WITH ADDITIONAL IMPLANTS, LYSIS OF ADHESIONS, DISSECTION OF PREVIOUS MESH WHICH HAD SPLIT APART AND BACK TO ICU POST-SURGERY.

  Patient problems: Abscess; Adhesion(s); Erosion; Excessive Tear Production; Hematoma; Hernia; Injury; No Code Available

  MAUDE report 8768913 ↗
• 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 A VENTRAL HERNIA REPAIR IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, SEROMA, CHRONIC DRAINING FISTULA, ADHESIONS, ABSCESS, PAIN, WOUND NECROSIS, SCARRING, AND THE HERNIA CONTAINED LOOP OF COLON AND OMENTUM. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES, WOUND DEBRIDEMENT, INCISIONAL HERNIA REPAIR, REMOVAL OF INFECTED MESH, FISTULOUS TRACT COMPLETELY EXCISED, LYSIS OF ADHESIONS, PLACEMENT OF NEW MESH AND INCISION AND DRAINAGE OF SEROMA.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Depression; Discharge; Emotional Changes; Fibrosis; Fistula; Fluid Discharge; Foreign Body Reaction; Hernia; Inflammation; Injury; Necrosis; No Code Available; Pain; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8688305 ↗
• 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED, HERNIA RECURRENCE, ADHESIONS, OBSTRUCTION DUE TO STRANGULATED HERNIA, SCAR TISSUE, BULGING, PAIN, AND NAUSEA. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REVISION SURGERIES, LYSIS OF ADHESIONS AND REVISION OF SCAR TISSUE.

  Patient problems: Abdominal Distention; Adhesion(s); Hernia; Injury; Nausea; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 8686969 ↗
• InjuryApr 29, 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 RECURRENT HERNIA WITH OBSTRUCTION. THE PRESENCE OF INTESTINAL ADHESIONS WERE NOTED DURING IMPLANT. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED BOWEL OBSTRUCTION, HERNIA RECURRENCE, ADHESIONS, AND MESH INFECTION. POST-OPERATIVE TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Fistula; Hernia; Injury; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 8562100 ↗
• InjuryApr 9, 2019Loss of or Failure to Bond; Degraded; Material Erosion; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Degraded; 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTED ABDOMINAL WOUND, INFECTED MESH, NECROTIZING INFECTION OF ABDOMINAL WALL AND PURULENT MATERIAL OVER MESH, HIGH TEMPERATURE, GROSS PURULENCE, NON-HEALING SURGICAL WOUND WITH NECROTIC TISSUE, SEPARATION OF SKIN EDGES WITH WOUND DRAINAGE, PURULENT DRAINAGE, NECROSIS OF ABDOMINAL WALL, FEVER, EXPOSED BIOLOGIC MESH, MESH WAS PARTIALLY DISINTEGRATED AND SEPARATION OF SKIN EDGES. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND EXPLORATION, DEBRIDEMENT OF COPIOUS NECROTIC MATERIAL, DEBRIDEMENT OF NONVIABLE TISSUE, REMOVAL OF MESH AND WOUND VAC PLACED.

  Patient problems: Bacterial Infection; Erosion; Fever; Hernia; Impaired Healing; Injury; Necrosis; Purulent Discharge; Staphylococcus Aureus; Unspecified Infection

  MAUDE report 8495298 ↗