Parietex PNP6X3Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 20884521176420), received between Sep 15, 2017 and May 1, 2026 — classified as 109 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (44 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 109 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Adverse 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Emotional Changes; Pain; Unspecified Tissue Injury

  MAUDE report 25057581 ↗
• InjuryOct 24, 2025Adverse 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, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23383935 ↗
• InjuryAug 22, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; 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 EMOTIONAL DISTRESS, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Discomfort; Distress; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22874099 ↗
• InjuryApr 17, 2025Adverse 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 PAIN, RECURRENCE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH AND MEDICATION.

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

  MAUDE report 21862095 ↗
• InjurySep 3, 2024Adverse 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 PAIN, RECURRENCE, DENSE SCAR TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 20131368 ↗
• InjuryJul 22, 2024Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, SCAR TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Adhesion(s); Emotional Changes; Fibrosis; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 19802212 ↗
• InjuryJun 10, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, ILIOINGUINAL NEURECTOMY.

  Patient problems: Adhesion(s); Constipation; Distress; Emotional Changes; Hernia; Nerve Damage; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19504901 ↗
• InjuryJun 22, 2023Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; Mechanics Altered; 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, SUFFERING, EMOTIONAL DISTRESS, MENTAL PAIN, INFECTIONS, BOWEL PROBLEMS, DEFECTIVE DEVICE, MENTAL ANGUISH, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND WOUND VAC.

  Patient problems: Abscess; Adhesion(s); Alteration in Body Temperature; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Atrophy; Burning Sensation; Discomfort; Distress; Emotional Changes; Erythema; Fever; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hyperresponsive to stimuli; Inflammation; Nerve Damage; Neuralgia; Neuropathy; Numbness; Pain; Paresthesia; Rash; Reduced Blood Flow; Scar Tissue; Seroma; Skin Discoloration; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17183534 ↗
• InjuryJun 2, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; 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 DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, INFLAMMATION, NERVE DAMAGE, SCAR TISSUE, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 17052643 ↗
• InjuryJun 2, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; 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 BILATERAL INGUINAL AND PANTALOON HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, INFLAMMATION, NERVE DAMAGE, SCAR TISSUE, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 17052607 ↗
• InjuryJun 2, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; 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 BILATERAL INGUINAL AND PANTALOON HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, INFLAMMATION, NERVE DAMAGE, SCAR TISSUE, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 17052596 ↗
• InjuryJun 2, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; 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 BILATERAL INGUINAL AND PANTALOON HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, INFLAMMATION, NERVE DAMAGE, SCAR TISSUE, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 17052587 ↗
• InjuryJan 27, 2023Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, MESH MIGRATION, MESH BALLED, PAIN, EMOTIONAL DISTRESS, MENTAL PAIN, INFECTION, ABSCESS, NECROSIS, INFLAMMATION, ADHESIONS, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, TESTICULAR PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HOSPITALIZATION, TREAT THE INFECTION, DRAIN ABSCESSES, DEBRIDE NECROTIC TISSUE.

  Patient problems: Abscess; Adhesion(s); Discomfort; Distress; Emotional Changes; Hernia; Inflammation; Necrosis; Nerve Damage; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16257568 ↗
• InjuryJan 17, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, MESH WADDED, FAILURE OF MESH, PAIN, MENTAL PAIN, NERVE DAMAGE, RECURRENCE, SCARRING, INFLAMMATION, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, NERVE ENTRAPMENT, FIBROSIS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Discomfort; Emotional Changes; Fibrosis; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 16188079 ↗
• InjurySep 23, 2022Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Integrity 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FOLDED UP, MENTAL ANGUISH, DEFECTIVE DEVICE, MESH FAILED, PAIN, MENTAL PAIN, INFLAMMATION, DISCOMFORT, IMPAIRMENT, EMOTIONAL DISTRESS, DISABILITY, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diarrhea; Discomfort; Distress; Emotional Changes; Hematoma; Hemorrhage/Blood Loss/Bleeding; Inflammation; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 15473361 ↗
• InjurySep 15, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED TENDERNESS, DISCOMFORT, RECURRENCE, PAIN, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, DEFECTIVE DEVICE, MESH FAILURE, MENTAL PAIN, SUFFERINGS, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Discomfort; Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Sexual Dysfunction; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15433006 ↗
• InjuryApr 7, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, PAIN, MENTAL ANGUISH, EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, DISCOMFORT, INFLAMMATION, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Discomfort; Distress; Emotional Changes; Hernia; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 14042776 ↗
• InjuryOct 26, 2021Mechanics 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 RIGHT GROIN HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SUFFERING, ILIOINGUINAL NERVE IDENTIFIED WITH CUT EDGE WITHIN MESH AND SCAR TISSUE, SPERMATIC CORD SCARRED AND UNABLE TO BE SEPARATED FROM FIBROTIC TISSUE, GROIN PAIN, CAN'T SLEEP, NERVE DAMAGE, HEADACHE, RECURRENT HERNIA, ADHESIONS, SCARRING, INFLAMMATORY RESPONSES, DISCOMFORT, PAIN, MENTAL PAIN/ANGUISH, DISABILITY, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, EMOTIONAL DISTRESS, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH EXCISION WITH TRIPLE NEURECTOMY, REMOVAL OF TESTICLE, AND AN ORCHIECTOMY.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Discomfort; Distress; Emotional Changes; Fibrosis; Headache; Hernia; Inflammation; Myalgia; Nausea; Nerve Damage; Pain; Scar Tissue; Sleep Dysfunction; Unspecified Tissue Injury

  MAUDE report 12698979 ↗
• InjuryOct 18, 2021Degraded; 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, HERNIA RECURRENCE, HARDENING, MESH MIGRATION, ADHESIONS AND NERVE INJURY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, TRANSABDOMINAL PREPERITONEAL DIAGNOSTIC LAPAROSCOPY, MESH PLACEMENT.

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

  MAUDE report 12652704 ↗
• InjuryOct 18, 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN, MESH MIGRATION, ADHESIONS, FIBROTIC REACTION, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 12646878 ↗
• InjuryOct 18, 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN, MESH MIGRATION, ADHESIONS, FIBROTIC REACTION, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 12646861 ↗
• InjurySep 9, 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 INDIRECT INGUINAL 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 12448853 ↗
• InjurySep 2, 2021Mechanics 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC INFLAMMATION, NUMEROUS FOAMY MACROPHAGES, SCARRING, NECROSIS, SEVERE AND CHRONIC PAIN/DISCOMFORT, DEFECTIVE DEVICE, MESH FAILURE, PAIN, MENTAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Hernia; Inflammation; Necrosis; Nerve Damage; Nodule; Numbness; Pain; Scar Tissue; Sexual Dysfunction; Unspecified Tissue Injury

  MAUDE report 12416418 ↗
• InjuryJul 29, 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 THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, MESH BALLED UP, FOREIGN BODY GIANT CELL REACTION, FIBROSIS, INFLAMMATION, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH (NON-MEDTRONIC PRODUCT), MESH REMOVAL, HERNIA SAC OPENED/EXCISED, AND REVISION SURGERY.

  Patient problems: Fibrosis; Foreign Body Reaction; Hernia; Inflammation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12247972 ↗
• InjuryMay 20, 2021Mechanics 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SCARRING, SMALL BOWEL INJURY, RECURRENCE, NAUSEA, DIARRHEA, ABDOMINAL PAIN, SCAR TISSUE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, AND HERNIA REPAIR.

  Patient problems: Abdominal Pain; Adhesion(s); Diarrhea; Emotional Changes; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Ischemia; Nausea; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11856805 ↗