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ProGrip TEM1515GRecalls & reported problems

Sofradim Production · Self-Gripping Polyester Mesh,Polyester with Polylactic Acid Grips · Class 2 · Implant

Quick summary

This Sofradim ProGrip is a self-gripping polyester mesh used to repair hernias. Many of its 288 reports describe hernias returning, pain, scar tissue and the mesh moving out of place, and some describe infection and fluid build-up. The reports include 283 injuries and no deaths. 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
288
Deaths reported
0
Injuries reported
283
Recalls naming it
0

Summary

The FDA's MAUDE database contains 288 adverse event reports that list this exact device (DI 10884521177727), received between Sep 15, 2017 and Jun 4, 2026 — classified as 283 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (116 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.

Reports received per month

Nov 2023: 4 reportsDec 2023: 4 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 2 reportsAug 2024: 2 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 3 reportsApr 2025: 0 reportsMay 2025: 2 reportsJun 2025: 2 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 2 reportsOct 2025: 0 reportsNov 2025: 2 reportsDec 2025: 3 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 2 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem282
  • Mechanics Altered116
  • Migration or Expulsion of Device74
  • Patient Device Interaction Problem39
  • Insufficient Device Problem Information19
  • Material Split, Cut or Torn17
  • Material Integrity Problem9
  • Loss of or Failure to Bond8

Patient problems

  • Hernia231
  • Pain212
  • Unspecified Tissue Injury201
  • Adhesion(s)176
  • Injury146
  • Emotional Changes116
  • Scar Tissue112
  • Inflammation108

Recent adverse event reports

The 25 most recent of 288 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 4, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, SUFFERING, SEROMA, NONHEALING SURGICAL WOUND, ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, UNILATERAL TRUNCAL COMPONENT RELEASE, MESH REVISION AND INCISION AND DRAINAGE.

    Patient problems: Abdominal Pain; Hernia; Impaired Healing; Pain; Seroma; Unspecified Tissue Injury

    MAUDE report 25394730 ↗
  • InjuryApr 21, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED OBSTRUCTION, RECURRENCE, PAIN, SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, HERNIA REPAIR WITH NEW MESH, DIAGNOSTIC LAPAROSCOPY.

    Patient problems: Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

    MAUDE report 24942307 ↗
  • InjuryApr 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SCAR TISSUE, ADHESIONS, ABSCESS, GRANULOMA, INFECTION, NONHEALING ABDOMINAL WOUND, OBSTRUCTION, RECURRENCE, PAIN, SUFFERING, SEROMA, CELLULITIS, SEROUS FLUID DRAINAGE, ABDOMINAL WALL NECROSIS, ABDOMINAL PAIN, WOUND DEHISCENCE AND FLUID COLLECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, HERNIA REPAIR WITH NEW MESH, DRAINAGE OF SEROMA, EXCISION OF SCAR TISSUE, TISSUE TRANSFER, NEGATIVE PRESSURE DRESSING, JP DRAIN PLACEMENT, ADHESIOLYSIS, INCISION AND DRAINAGE, EXCISION OF ABSCESS, TISSUE LAVAGE, DEBRIDEMENT, CT GUIDED DRAINAGE OF ABDOMINAL WALL FLUID COLLECTION AND EXCISION OF GRANULOMA.

    Patient problems: Abdominal Pain; Abscess; Adhesion(s); Ascites; Cellulitis; Fluid Discharge; Granuloma; Hernia; Impaired Healing; Necrosis; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

    MAUDE report 24835893 ↗
  • InjuryDec 16, 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 RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH AND MEDICATION.

    Patient problems: Hernia; Pain; Unspecified Tissue Injury

    MAUDE report 23821856 ↗
  • InjuryDec 16, 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

    Patient problems: Abscess; Distress; Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 23819229 ↗
  • InjuryDec 16, 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

    MAUDE report 23819201 ↗
  • InjuryNov 26, 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, ADHESIONS, PROBLEMS SLEEPING, ANXIETY, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, MEDICATION AND USE OF ABDOMINAL BINDER.

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

    MAUDE report 23659597 ↗
  • InjuryNov 20, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, SCARRING, BURNING SENSATION, AND CRAMPS. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL MESH IMPLANTED, INTERVENTION SURGERY AND MESH REMOVAL SURGERY.

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

    MAUDE report 23610577 ↗
  • MalfunctionSep 17, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

    IT WAS REPORTED THAT DURING A ROBOTIC TRANSABDOMINAL RETROMUSCULAR UMBILICAL PROSTHETIC HERNIA REPAIR (TARUP), INVOLVING PLACEMENT OF MESH IN A SUB-UMBILICAL HERNIA LOCATED IN THE CESAREAN SECTION SCAR. THE SURGEON EXPERIENCED DIFFICULTY ATTACHING THE MESH PROPERLY, PARTICULARLY AT THE EDGES, AS IT REPEATEDLY FELL DOWN DURING PLACEMENT IN BOTH PRE-PERITONEAL AND RETRO RECTUS PLANES. TO FIX THE ISSUE, IT NEEDED TO MANUALLY HOLD UP THE MESH TO PREVENT IT FROM FALLING DURING PLACEMENT. THE WOUND WAS THEN CLOSED WITH A SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23080079 ↗
  • MalfunctionSep 16, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

    ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE MESH WAS NOT STICKING PROPERLY TO THE TISSUE. THE SURGEON USED TO PLACE THE MESH RETRO RECTUS AND HAS CHANGED TO PRE-PERITONEAL AS FIRST CHOICE. HOWEVER, THE SURGEON FELT THAT THE MESH DOES NOT ATTACH VERY WELL EITHER PRE-PERITONEAL OR RETRO RECTUS.

    Patient problems: Insufficient Information

    MAUDE report 23069145 ↗
  • InjuryJul 14, 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, ADHESIONS, EMOTIONAL CHANGES, LOOSE ABDOMEN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

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

    MAUDE report 22500796 ↗
  • InjuryJun 23, 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 MESH MIGRATION, PAIN, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, AND ORCHIECTOMY.

    Patient problems: Hernia; Pain; Unspecified Tissue Injury

    MAUDE report 22311731 ↗
  • InjuryJun 20, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, MEDICATION, AND POSTERIOR COMPONENTS PARTS SEPARATION.

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

    MAUDE report 22299726 ↗
  • InjuryMay 27, 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, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

    Patient problems: Adhesion(s); Discomfort; Distress; Emotional Changes; Hernia; Nerve Damage; Pain; Sexual Dysfunction; Unspecified Tissue Injury

    MAUDE report 22090733 ↗
  • InjuryMay 1, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, PAIN, RECURRENCE, ADHESIONS, OBSTRUCTION, EMOTIONAL HARM, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

    Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

    MAUDE report 21947033 ↗
  • InjuryMar 31, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED A RECURRENCE, ADHESIONS, OBSTRUCTIONS, PAIN, SUFFERING, AND DEFECTIVE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

    MAUDE report 21733399 ↗
  • InjuryMar 18, 2025Adverse 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 PAIN, RECURRENCE, ADHESIONS, SEROMA, PERFORATION, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, AND PANNICULECTOMY.

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

    MAUDE report 21634824 ↗
  • InjuryMar 11, 2025Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 DEFECTIVE MESH, FAILURE OF MESH, MESHOMA, MESH EXTRUSION, DISCOMFORT, INFLAMMATION, MESHOMA, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH.

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

    MAUDE report 21574324 ↗
  • InjuryJan 24, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, DISCOMFORT, INFLAMMATION, RECURRENCE, ADHESIONS, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION.

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

    MAUDE report 21232707 ↗
  • InjuryJan 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, ADHESIONS, PAIN, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH.

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

    MAUDE report 21180154 ↗
  • InjuryOct 30, 2024Mechanics 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH.

    Patient problems: Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

    MAUDE report 20570734 ↗
  • InjuryOct 1, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, INFLAMMATION, ADHESIONS, INFECTION, NERVE DAMAGE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

    MAUDE report 20346055 ↗
  • InjuryAug 9, 2024Mechanics 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, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

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

    MAUDE report 19954865 ↗
  • InjuryAug 9, 2024Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEROMA, CELLULITIS, ABSCESS, RECURRENCE, ADHESIONS, MESH FAILURE, MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

    Patient problems: Abscess; Adhesion(s); Cellulitis; Hernia; Seroma; Unspecified Tissue Injury

    MAUDE report 19954314 ↗
  • InjuryJul 18, 2024Degraded; 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, INFLAMMATION, ALLERGIC REACTION, ADHESIONS, FISTULAS, DISINTEGRATION OF MESH, ENTEROTOMIES, SCARRING, PLEURAL EFFUSION, FIBROSIS, HEMORRHAGE, DISCOMFORT, RECURRENCE, PRESSURE IN ABDOMEN, BOWEL PROBLEMS, DIFFICULTY EATING AND DIGESTING CERTAIN FOODS, FREQUENT URINATION, UNABLE TO EXERCISE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MULTIPLE JP DRAINS, WOUND VAC, EXPLORATORY LAPAROTOMY, 6" RESECTION OF DISTAL ILEUM, PICC LINE, TPN NEEDED, NURSING HOME REHAB, INFUSION SERVICES AT HOME, BLOOD TRANSFUSIONS, HERNIA REPAIR WITH NEW MESH, MEDICATION.

    Patient problems: Abdominal Distention; Adhesion(s); Decreased Appetite; Discomfort; Fibrosis; Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Obstruction/Occlusion; Pain; Pleural Effusion; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Urinary Frequency / Polyuria

    MAUDE report 19776185 ↗

Other Mesh, surgical, polymeric devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.