Permacol P151520Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884523000184), received between Sep 21, 2017 and Mar 3, 2025 — classified as 41 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2025Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Mechanics Altered; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, OBSTRUCTIONS, BOWEL ISSUES, MESH FAILURE, INFECTION, FISTULA, ADHESIONS, CHRONIC PAIN, HEMATOMA, LABS ABNORMAL FOR RBC; HEMOGLOBIN; HEMATOCRIT; ALBUMIN; BUN; GLUCOSE; PHOSPHOROUS, FLUID COLLECTION, SEROMA, FOREIGN BODY GIANT CELL REACTION, SUTURE GRANULOMA, FIBROADIPOSE TISSUE, ULCERATION, INFLAMMATION, MUCOSA SHOWS FOCI OF SUPERFICIAL EROSION, GAS PAINS, CONSTIPATION, ABDOMINAL PAIN, DISCOMFORT, BLOOD DRAINAGE FROM UMBILICAL INCISION, FEVER, DIARRHEA, PURULENT DISCHARGE, MESH UNINCORPORATED <(>&<)> FLOATING, ILEUM <(>&<)> COLON DILATED, COLON THINNER WALLED, ENTERIC CONTENTS DRAINING FROM VAGINA, SEXUAL INTERCOURSE UNCOMFORTABLE, SEROSAL TEARS, THIN APEX OF VAGINA, RETAINED STOOL, EROSION OF MESH INTO BOWEL, SCARRING, <(>&<)> ATTENUATED MUSCLE FASCIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, REVISION SURGERY, SMALL BOWL RESECTION, COLON RESECTION, WOUND VAC, CT SCAN, PHYSICAL THERAPY, IV FLUID, MEDICATION, MULTIPLE HOSPITALIZATIONS, EVACUATION OF HEMATOMA, IV H

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Constipation; Diarrhea; Discomfort; Electrolyte Imbalance; Erosion; Fever; Fistula; Flatus; Foreign Body Reaction; Granuloma; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Seroma; Sexual Dysfunction; Ulcer; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21506465 ↗
• InjuryNov 29, 2022Adverse 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 PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, FISTULAS, AND BULGING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, JP DRAIN, AND MEDICATION.

  Patient problems: Abdominal Distention; Adhesion(s); Fistula; Hernia; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15881418 ↗
• InjuryNov 15, 2022Migration 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, SMALL BOWEL OBSTRUCTION, PAIN, MESH EROSION, MESH MIGRATION, FIBROMEMBRANOUS TISSUE WITH MESOTHELIAL-LINING, INFLAMMATION, REDNESS, SWELLING, DRAINAGE, INDURATION, NAUSEA, VOMITING, CHILLS, CONSTIPATION, DIARRHEA, DRAINING EXUDATE, DEEP TRACT, ABDOMINAL PAIN, FEVER, LOOSE BOWEL MOVEMENTS, ABSCESS, AND ENTEROTOMY. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC, CT SCAN, ADMISSION TO HOSPITAL, MEDICATION, ABDOMINAL WOUND DEBRIDEMENT, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, REPAIR OF ENTEROTOMY, LYSIS OF ADHESIONS, EXCISION OF WOUND TRACT, AND SMALL BOWEL RESECTION.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Constipation; Diarrhea; Erosion; Erythema; Fever; Fistula; Fluid Discharge; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Perforation; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 15800927 ↗
• InjuryMay 14, 2021Migration 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED BALLED UP MESH, INFECTION, PAIN, MESH MIGRATION, SCAR TISSUE, FIBROFATTY TISSUE, INFLAMMATION, GRANULOMATOUS (FOREIGN BODY) LESIONS, STAPHYLOCOCCUS AUREUS, METHICILLIN SUSCEPTIBLE, PURULENT DRAINAGE, ADHESIONS, OPEN WOUND, ABSCESS, AND FAILURE OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLANT OF MESH, DEBRIDEMENT OF SCARTISSUE, REMOVAL OF SUTURES, SCAR TISSUE EXCISED, OPEN WOUND PACKED, AND INCISION/DRAINAGE OF ABSCESS.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Foreign Body Reaction; Granuloma; Impaired Healing; Inflammation; Purulent Discharge; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11828642 ↗
• 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 11792668 ↗
• InjuryMar 20, 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 AND A PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER THE UNDERLAY IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, SEROMA, INFECTION, ABSCESS, THICKENED/EDEMATOUS FASCIA, FREE FLOATING MESH, INFLAMMATION, NECROTIC TISSUE, NON-HEALING WOUND, PURULENT MATERIAL, KELOID SCAR, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, DRAINAGE OF ABSCESS, WOUND IRRIGATED, WOUND PACKED, DEBRIDEMENT OF ABDOMINAL WALL INFECTED MESH, KELOID SCAR EXCISED, AND REMOVAL OF MESH.

  Patient problems: Abscess; Failure of Implant; Hernia; Impaired Healing; Inflammation; Necrosis; Purulent Discharge; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11536660 ↗
• 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 AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11124219 ↗
• InjuryDec 1, 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 INFECTION, RECURRENCE, ADHESIONS, INFLAMMATION, AND FISTULAZATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH EXCISION.

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

  MAUDE report 10928008 ↗
• 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 AN ABDOMINAL 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 AND WOUND VAC.

  Patient problems: Adhesion(s); Fistula; Hernia; Impaired Healing; Pain; Scar Tissue; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 10906457 ↗
• InjuryNov 15, 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, ADHESIONS, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, HERNIA SAC RESECTED, AND ADMISSION TO ICU.

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

  MAUDE report 10841774 ↗
• InjurySep 24, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, ABDOMINAL WALL ABSCESS, AND SMALL BOWEL PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, SMALL BOWEL RESECTION, HERNIA REPAIR WITH NEW MESH, EXPLORATORY LAPAROTOMY, AND LYSIS OF ADHESIONS.

  Patient problems: Abscess; Adhesion(s); Hernia; Injury; Internal Organ Perforation

  MAUDE report 10582981 ↗
• InjurySep 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, OBSTRUCTION, FISTULA, ABDOMINAL PAIN, MESH INFECTION, SCARRING, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, MESH EXCISION.

  Patient problems: Abdominal Pain; Adhesion(s); Fistula; Hernia; Inflammation; Injury; Obstruction/Occlusion; Pain; Scar Tissue; Scarring; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10582908 ↗
• InjurySep 23, 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 THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, OBSTRUCTION, FISTULA, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 10574688 ↗
• InjurySep 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 AN INCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED UNINCORPORATED MESH, RECURRENCE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED COMPONENT SEPARATION AND REMOVAL OF MESH.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 10560268 ↗
• InjurySep 8, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE INLAY IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, MESH HAD PARTIALLY DISSOLVED, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND MESH REMOVAL.

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

  MAUDE report 10503127 ↗
• 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, RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 10311075 ↗
• InjuryJul 13, 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. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Hernia; Injury

  MAUDE report 10268064 ↗
• InjuryJun 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH SEPARATION, OPEN DRAINING WOUND AND SINUS TRACT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Fluid Discharge; Impaired Healing; Injury; No Code Available

  MAUDE report 10125591 ↗
• InjuryMay 28, 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, BOWEL OBSTRUCTION, ADHESIONS AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS AND REVISION SURGERY.

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

  MAUDE report 10097451 ↗
• InjuryMar 13, 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 SMALL BOWEL OBSTRUCTION AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 9828347 ↗
• InjuryMar 4, 2020Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Mechanics Altered; 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 UNINCORPORATED MESH, RECURRENCE, INFECTION, ADHESIONS, FISTULA, ABSCESS, RECTUS MUSCLE IS ATROPHIC, MESH SEPARATED, CANDIDA ALBICANS, COCCI, MASS, CONSTIPATION, WEIGHT FLUCTUATIONS, DISCOMFORT, FEVER, YEAST SEPTICEMIA, NAUSEA, DRAINING OPEN WOUND, DEFECTIVE DEVICE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ADMISSION TO HOSPITAL, ANTIBIOTICS, CENTRAL VENOUS CATHETER, TPN, WOUND VAC, LEUKOCYTE ESTERASE TEST, CT SCAN.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Constipation; Discomfort; Emotional Changes; Fever; Fistula; Fluid Discharge; Fungal Infection; Hernia; Impaired Healing; Injury; Muscle Weakness/Atrophy; Nausea; Pain; Unspecified Infection; Unspecified Tissue Injury; Weight Changes

  MAUDE report 9784589 ↗
• InjuryFeb 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, INFECTION, OPEN DRAINING WOUND, HEMATOMA, INFLAMMATION, FISTULA, SEROMA AND INFLAMMATORY STRANDINGS. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGERY TO REMOVE MESH AND ADDITIONAL IMPLANT.

  Patient problems: Adhesion(s); Discharge; Fistula; Hematoma; Impaired Healing; Inflammation; Injury; No Code Available; Seroma; Unspecified Infection

  MAUDE report 9766934 ↗
• InjuryJan 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, OPEN DRAINING WOUND, ABSCESS, CALCIFICATION, INFLAMMATION, NECROSIS AND FOREIGN BODY GIANT CELL REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Calcium Deposits/Calcification; Discharge; Foreign Body Reaction; Impaired Healing; Inflammation; Injury; Necrosis; Unspecified Infection

  MAUDE report 9617161 ↗
• InjuryJan 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 IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE AND ADHESIONS. POST-IMPLANT TREATMENT INCLUDED ADHESION REMOVAL, BOWEL RESECTION, AND ILEOSTOMY.

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

  MAUDE report 9610354 ↗
• InjuryDec 16, 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, WOUND DEHISCENCE WITH EVISCERATION, GROSSLY DISTENDED ABDOMEN, DRAINAGE FROM SKIN INCISION, BOWEL NEARLY PROTRUDING THROUGH SKIN INCISION, LIGHT FIBRINOUS INFLAMMATORY ADHESIONS, EXTENSIVE GASEOUS DISTENDED ILEUS, SEPSIS, RESPIRATORY FAILURE, PURULENT MATERIAL IN SUBCUTANEOUS SPACE, FIBRINOUS ADHESIONS, ABDOMINAL BLOATING, NAUSEA, VOMITING, NON-HEALING WOUND ON ABDOMEN, BOWEL OBSTRUCTION, DEHYDRATION, ACUTE RENAL FAILURE, LEUKOCYTOSIS, AND MULTIPLE HOSPITALIZATIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES, LYSIS OF ADHESIONS, EXPLORATORY LAPAROTOMY, AND MESH REMOVAL.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dehydration; Fibrosis; Fistula; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Injury; Nausea; No Code Available; Obstruction/Occlusion; Pain; Purulent Discharge; Renal Failure; Respiratory Failure; Sepsis; Unspecified Infection; Unspecified Tissue Injury; Vomiting; Wound Dehiscence

  MAUDE report 9472741 ↗