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ProGrip LPG1510ALRecalls & reported problems

Sofradim Production · Laparoscopic Self-Fixating Mesh, Left Anatomical · Class 2 · Implant

All models of ProGrip (24)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Sofradim ProGrip laparoscopic mesh is an implanted surgical mesh used to repair hernias. Its 219 reports mostly describe hernias coming back, pain, adhesions, and the mesh shifting, splitting or tearing, and many relay allegations made by patients' attorneys. The reports include 1 death and 189 injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
219
Deaths reported
1
Injuries reported
189
Recalls naming it
0

Summary

The FDA's MAUDE database contains 219 adverse event reports that list this exact device (DI 10884521513174), received between Sep 19, 2017 and Aug 11, 2026 — classified as 1 death, 189 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (86 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 2 reportsJan 2024: 0 reportsFeb 2024: 7 reportsMar 2024: 0 reportsApr 2024: 2 reportsMay 2024: 1 reportsJun 2024: 4 reportsJul 2024: 2 reportsAug 2024: 1 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 4 reportsFeb 2025: 2 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 3 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 3 reportsDec 2025: 3 reportsJan 2026: 2 reportsFeb 2026: 1 reportsMar 2026: 1 reportsApr 2026: 2 reportsMay 2026: 2 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 2 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem190
  • Mechanics Altered86
  • Migration or Expulsion of Device59
  • Material Split, Cut or Torn24
  • Insufficient Device Problem Information18
  • Patient Device Interaction Problem17
  • Material Integrity Problem12
  • Material Deformation7

Patient problems

  • Pain155
  • Hernia152
  • Unspecified Tissue Injury145
  • Adhesion(s)94
  • Emotional Changes89
  • Injury75
  • Scar Tissue75
  • Inflammation60

Recent adverse event reports

The 25 most recent of 219 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 11, 2026Mechanics Altered; Adverse Event Without Identified Device or Use Problem

    The patient¿s attorney alleged a deficiency against the device. The product was used for a laparoscopic therapeutic treatment of a bilateral inguinal hernia. It was reported that after implant, the patient experienced abdominal pain, recurrent hernia, rectus diastasis, defective mesh, pain, suffering, emotional distress, disability, impairment, and loss of enjoyment of life. Post-operative patient treatment included resection of skin and subcutaneous tissue and mesh removal.

    Patient problems: Abdominal Pain; Distress; Emotional Changes; Hernia; Muscle Weakness/Atrophy; Pain; Unspecified Tissue Injury

    MAUDE report 50216870 ↗
  • MalfunctionAug 11, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50202258 ↗
  • InjuryMay 19, 2026Adverse 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, HERNIA RECURRENCE, ADHESIONS, PAIN, <(>&<)> SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, <(>&<)> HERNIA REPAIR WITH MESH.

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

    MAUDE report 25219882 ↗
  • InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

    PLI 10: THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, CORD LIPOMA, RECURRENCE, PAIN, SUFFERING, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL INTERVENTION, HERNIA REPAIR, RESECTION OF CORD LIPOMA AND MESH REVISION. PLI 20: THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, CORD LIPOMA, RECURRENCE, PAIN, SUFFERING, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL INTERVENTION, HERNIA REPAIR AND RESECTION OF CORD LIPOMA.

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

    MAUDE report 25219217 ↗
  • InjuryApr 24, 2026Adverse 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 ADHESIONS, RECURRENCE, PAIN, HEMATOMA, SUFFERING AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, OPEN RIGHT GROIN EXPLORATION, REMOVAL OF FOREIGN BODY, MESH REVISION, INCISION AND DRAINAGE OF RIGHT INGUINAL SUBCUTANEOUS HEMATOMA, ROBOTIC ASSISTED LAPAROSCOPIC LYSIS OF ADHESIONS AND HERNIA REPAIR WITH NEW MESH.

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

    MAUDE report 24988344 ↗
  • InjuryApr 22, 2026Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

    PLI:10 THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, SUFFERING, ANXIETY AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, HERNIA REPAIR AND MESH REVISION. PLI:20 THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FOLDED MESH, ADHESIONS, RECURRENCE, PAIN, SUFFERING, ANXIETY AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, HERNIA REPAIR AND MESH REMOVAL.

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

    MAUDE report 24960780 ↗
  • InjuryMar 9, 2026Adverse 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 EMOTIONAL DISTRESS, ADHESIONS, BOWEL OBSTRUCTION, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, EXPLORATORY LAPAROTOMY, AND MESH REVISION.

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

    MAUDE report 24550452 ↗
  • InjuryFeb 3, 2026Migration 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, ADHESIONS, RECURRENCE, PAIN AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR AND MESH REVISION.

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

    MAUDE report 24249254 ↗
  • InjuryJan 28, 2026Migration 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 MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

    MAUDE report 24202777 ↗
  • InjuryJan 20, 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 AND UMBILICAL 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 24121435 ↗
  • InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Split, Cut or Torn

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL AND INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, MESH FAILURE, FRACTURED MESH, HERNIA INCARCERATION, AND DIFFICULTY BENDING OVER AND REACHING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, BILATERAL COMPONENT SEPARATION, AND JP DRAIN USE.

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

    MAUDE report 23794340 ↗
  • InjuryDec 4, 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.

    Patient problems: Hernia; Pain; Unspecified Tissue Injury

    MAUDE report 23719517 ↗
  • InjuryDec 1, 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, MEDICATION.

    Patient problems: Hernia; Pain; Unspecified Tissue Injury

    MAUDE report 23688578 ↗
  • InjuryNov 26, 2025Migration 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 MESH MIGRATION, MESH EXTRUSION, UNABLE TO HAVE SEX, INFLAMMATION, NERVE DAMAGE, PAIN, RECURRENCE, EMOTIONAL CHANGES. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

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

    MAUDE report 23659267 ↗
  • InjuryNov 17, 2025Migration 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, INCARCERATED HERNIA, MESH MIGRATION, CONSTIPATION, CRAMPS, INTESTINE STRANGULATION, INTESTINE TANGLED IN MESH AND TESTICULAR PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY, HERNIA REPAIR WITH NEW MESH AND MEDICATION.

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

    MAUDE report 23574439 ↗
  • InjuryNov 11, 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, INFLAMMATION, ADHESIONS AND GROIN PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY AND MEDICATION.

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

    MAUDE report 23528396 ↗
  • InjuryOct 15, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, HERNIA RECURRENCE, ADHESIONS, LOSS OF TESTICLES, NERVE DAMAGE, PAIN, SUFFERING, INGUINAL MASS, <(>&<)> UNDESCENDED TESTICLE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, EXPLORATION OF LEFT GROIN, <(>&<)> LEFT ORCHIECTOMY.

    Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Hernia; Nerve Damage; Nodule; Pain; Unspecified Tissue Injury

    MAUDE report 23304948 ↗
  • MalfunctionSep 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

    ACCORDING TO THE REPORTER, DURING A ROBOTIC PROCEDURE, THE MESH WAS TORN. THE DOCTOR DID NOT REMOVE THE MESH IN THE CAVITY AND INSTEAD PERFORMED A SUTURE REPAIR. THERE WAS NO PATIENT INJURY.

    Patient problems: Tissue Breakdown

    MAUDE report 23009675 ↗
  • InjuryAug 22, 2025Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, MESH MIGRATION, MESH SHRINKAGE, PAIN, ADHESIONS, RECURRENCE, NERVE DAMAGE, SEROMA, MESHOMA, URINARY TRACT INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, NEURECTOMY, LYSIS OF ADHESION, MESH REMOVAL.

    Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Hernia; Nerve Damage; Pain; Seroma; Unspecified Tissue Injury; Urinary Tract Infection

    MAUDE report 22873274 ↗
  • InjuryMay 19, 2025Mechanics 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 INGUINAL BILATERAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, RECURRENCE, PAIN, DISCOMFORT, AND EMOTIONAL HARM. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

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

    MAUDE report 22048138 ↗
  • InjuryMay 12, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, HEMATOMA, ABDOMINAL PAIN.

    Patient problems: Abdominal Pain; Hematoma; Hernia; Pain; Unspecified Tissue Injury

    MAUDE report 22006220 ↗
  • InjuryMay 2, 2025Mechanics 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 FAILURE OF MESH, PAIN, RECURRENCE, EMOTIONAL HARM, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

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

    MAUDE report 21955084 ↗
  • InjuryMar 19, 2025Migration 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, PAIN, RECURRENCE, ADHESIONS, FIBROSIS TO THE SPERMATIC CORD STRUCTURES, MESH EROSION, AND LEFT HYDROCELE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, MEDICATION, NERVE BLOCK, LEFT HYDROCELECTOMY, LEFT ORCHIECTOMY, AND COLON RESECTION.

    Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Fibrosis; Hernia; Pain; Unspecified Tissue Injury

    MAUDE report 21645294 ↗
  • InjuryFeb 7, 2025Migration 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 DEFECTIVE MESH, FAILURE OF MESH, MESH CONTRACTION, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR.

    Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

    MAUDE report 21335078 ↗
  • InjuryFeb 7, 2025Mechanics 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 DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR.

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

    MAUDE report 21334926 ↗

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