Permacol P152030Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884523000207), received between Oct 11, 2017 and Dec 19, 2022 — classified as 41 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (8 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 41 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Confusion/ Disorientation; Constipation; Diarrhea; Hernia; High Blood Pressure/ Hypertension; Nausea; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Tissue Injury; Vomiting

  MAUDE report 16003844 ↗
• InjuryJul 21, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER ONLAY IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Adhesion(s); Emotional Changes; Impaired Healing; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15076742 ↗
• 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT HERNIA DUE TO FAILURE OF THE MESH, BOWEL OBSTRUCTION, AND FIBROUS CAPSULE FORMED IN REACTION TO THE FAILED HERNIA MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL SURGERY.

  Patient problems: Failure of Implant; Fibrosis; Hernia; Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 12650518 ↗
• InjurySep 2, 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 ADHESIONS TO BOWEL, ADHESIONS, HERNIA RECURRENCE, WEAKENED ABDOMINAL WALL, AND SEVERE AND CHRONIC PAIN/DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WENT THROUGH PREVIOUS MESH, BILATERAL COMPONENT SEPARATION, LYSIS OF ADHESIONS, AND HERNIA REPAIR WITH MESH.

  Patient problems: Adhesion(s); Discomfort; Hernia; Muscle Weakness/Atrophy; Pain; Unspecified Tissue Injury

  MAUDE report 12416214 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENTS ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH, ADHESIONS, SEROSAL TEAR TO SIGMOID COLON, ABSCESS, GRAM POSITIVE COCCI, STAPHYLOCOCCUS AUREUS, INFLAMMATION, PAIN, CELLULITIS, SEROSAL TEAR, RECURRENCE, AND OPEN WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, ADHESION REMOVAL, ABSCESS DRAINAGE WITH INTRAPERITONEAL DRAIN PLACEMENT, WOUND VAC, HOSPITALIZATION, ANTIBIOTICS, LYSIS OF ADHESIONS, PERITONEAL LAVAGE, AND REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Cellulitis; Hernia; Impaired Healing; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12326876 ↗
• InjuryJul 15, 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 HERNIA RECURRENCE, FOREIGN BODY REACTION, ABSCESS, FLUID COLLECTION, SEVERE AND CHRONIC PAIN AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND ABDOMINAL WALL RECONSTRUCTION,.

  Patient problems: Abscess; Ascites; Discomfort; Foreign Body Reaction; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 12173808 ↗
• InjuryJul 2, 2021Migration 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ROLLED UP MESH, ABDOMINAL PAIN, MIGRATED MESH, ADHESIONS, SEROSAL DAMAGE TO BOWELS, HERNIA RECURRENCE, AND PAIN AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, AND REVISION SURGERY.

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

  MAUDE report 12112031 ↗
• 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 12109414 ↗
• InjuryJun 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED LARGE AMOUNT OF BOWEL WITHIN THE SUBCUTANEOUS TISSUE DEHISCED AROUND THE EDGES, MULTIPLE DILATED PROXIMAL SMALL LOOPS OF BOWEL, ADHESIONS, ABSCESS, NECROTIC FASCIA, ABDOMINAL COMPARTMENT SYNDROME AND ILEUS, FISTULA, SUCCUS DRAINAGE, FISTULA OCCLUSION, SEROMA, FEVER, ABDOMINAL PAIN, FASCIAL DEHISCENCE, SEROUS FLUID FROM WOUND, EDEMATOUS BOWEL, SMALL BOWEL OBSTRUCTION, ACUTE GANGRENOUS CHOLECYSTITIS, CENTRAL LINE SEPSIS, ACUTE RESPIRATORY DISTRESS SYNDROME, AND OPEN ABDOMINAL GRANULATION WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY OF PREVIOUSLY PLACED PERMACOL PATCH, ABDOMINAL VAC PLACED, ENTERIC CONTENTS WERE MILKED BACK INTO THE STOMACH AND ASPIRATED THROUGH THE NG TUBE, WOUND VAC, LYSIS OF ADHESIONS, DEBRIDING OF NECROTIC FASCIA, SUMP DRAIN FOR SMALL BOWEL FISTULA, SPLIT THICKNESS SKIN GRAFTS HARVESTED FROM THE LEFT LEG USING A DERMATOME AND APPLIED TO ENTIRE ABDOMINAL WALL, REMOVAL OF WOUND VAC, TUBE ENTEROSTOMY, HERNIA REPAIR WITH MESH, ABDOMINAL WASHOUT, HOSPI

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Adult Respiratory Distress Syndrome; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fever; Fistula; Fluid Discharge; Impaired Healing; Necrosis; Obstruction/Occlusion; Sepsis; Seroma; Swelling/ Edema; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 12025430 ↗
• InjuryJun 16, 2021Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A FEW DAYS POST-OPEN VENTRAL HERNIA REPAIR, THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION. RE-OPERATION WAS PERFORMED AND FOUND THAT THE MESH DEGRADED WITH HOLES. ANOTHER MESH FROM THE SAME BRAND WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12011549 ↗
• InjuryApr 30, 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 MESH FAILED, RECURRENCE, ADHESIONS, SKIN DEHISCENCE, LOSS OF DOMAIN, GRANULATION TISSUE, COLONIZED SUBCUTANEOUS FAT, AND CHRONIC WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, PLACEMENT OF JP DRAIN, LYSIS OF ADHESIONS, BIOPSIES, LYSIS OF ADHESIONS, REMOVAL OF MESH, FLAP, MYOCUTANEOUS OR FASCIOCUTANEOUS, TRUNK, UMBILECTOMY, OMPHALECTOMY, EXCISION UMBILICUS, ADJACENT TISSUE TRANSFER OR REARRANGEMENT, IV INJECTION, WOUND PACKED, AND CHRONIC WOUND DEBRIDEMENT.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Hernia; Impaired Healing; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11753380 ↗
• InjuryApr 23, 2021Degraded; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Degraded; 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 ADHESIONS, PAIN, CONTRACTED MESH, FLUID COLLECTIONS, BREAKDOWN OF MESH/MESH FRIABLE, DISCOMFORT, MESH DISINTEGRATION/FRAYING, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, HERNIA REPAIR, AND PARTIAL MESH REMOVAL.

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

  MAUDE report 11715900 ↗
• InjuryMar 5, 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 INFLAMMATION, INFECTION, ABSCESS, HERNIA, AND OPEN DRAINING WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, AND PARTIAL REMOVAL OF MESH.

  Patient problems: Abscess; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11421797 ↗
• 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 IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11124473 ↗
• InjuryDec 5, 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 IMPLANT, THE PATIENT EXPERIENCED INFECTION, ADHESIONS, ABSCESS, WOUND SEROMA, FLUID COLLECTION, DRAINING, SINUS TRACT, PURULENT MATERIAL, RECURRENCE, AND INFLAMMATORY RESPONSE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND PACKED OPEN, EXCISION OF TISSUES, LYSIS OF ADHESIONS, HERNIA REPAIR WITH NEW MESH, OSTOMY DEFECT CLOSED PRIMARILY, AND INCISION/DRAINAGE.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Fluid Discharge; Hernia; Inflammation; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10951479 ↗
• 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 10907125 ↗
• 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 10862397 ↗
• InjuryOct 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 INFECTION, ABSCESS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Injury; Pain; Unspecified Infection

  MAUDE report 10657910 ↗
• 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 ADHESIONS AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Discomfort; Fluid Discharge; Hernia; Injury; Pain; Perforation; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 10560315 ↗
• InjurySep 11, 2020Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; 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 PAIN, ADHESIONS, WRINKLED MESH, ABDOMINAL PAIN, RECURRENCE, SMALL INTUSSUSCEPTION, SEROSAL TEARS, AND SMALL BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, MESH REMOVAL, DIAGNOSTIC LAPAROSCOPY, EXPLORATORY LAPAROTOMY, REMOVAL OF TACKS, SEROSAL TEARS REPAIRED, AND LYSIS OF ADHESIONS.

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

  MAUDE report 10524868 ↗
• InjuryAug 10, 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 NON-HEALING WOUND AND SINUS TRACT DUE TO FAILURE OF THE MESH, THE MESH WAS POORLY INCORPORATED AND INFECTED. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY.

  Patient problems: Failure of Implant; Hernia; Impaired Healing; Injury; No Code Available; Unspecified Infection

  MAUDE report 10384364 ↗
• 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, ABDOMINAL PAIN, NAUSEA, VOMITING, TENDERNESS, ISCHEMIC BOWEL, VENOUS CONGESTION, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL REMOVAL, MAJORITY OF MESH REMOVED, NG TUBE, ADMITTED TO HOSPITAL, HERNIA REPAIR WITH NEW MESH, SMALL BOWEL RESECTION, PLACEMENT OF ARTERIAL LINE, FULL MESH REMOVAL, AND REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Hernia; Injury; Ischemia; Nausea; No Code Available; Unspecified Tissue Injury; Vomiting

  MAUDE report 10267716 ↗
• InjuryMay 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABSCESS, RECURRENCE, ADHESIONS, SEROSAL TEAR, DIATHESIS, STAPHYLOCOCCUS AUREUS, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, INCISION/DRAINAGE OF ABSCESS, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, REMOVAL OF SUTURE MATERIAL, WOUND PACKED, SEROSAL TEAR REPAIR, AND REMOVAL OF MESH.

  Patient problems: Abscess; Adhesion(s); Hernia; Injury; No Code Available; Scarring; Staphylococcus Aureus

  MAUDE report 10057772 ↗
• 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, FEVER, LEUKOCYTOSIS, ERYTHEMA, PURULENT MATERIAL, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, OPENING OF RECENT WOUND AND DRAINAGE OF ABSCESS.

  Patient problems: Abscess; Erythema; Fever; Injury; No Code Available; Unspecified Infection

  MAUDE report 9890019 ↗
• InjuryMar 6, 2020Mechanics 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION DUE TO FAILURE OF THE MESH, CONTINUOUS DRAINAGE, ABSCESS AND GRANULATION TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY.

  Patient problems: Abscess; Discharge; Failure of Implant; Fluid Discharge; Hernia; Injury; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9800038 ↗