ProGrip TEM1208GLRecalls & reported problems
Sofradim Production · Self-Gripping Polyester Mesh,Left Anatomical, Polyester with Polylactic Acid Grips · Class 2 · Implant
Quick summary
This Sofradim ProGrip mesh is a self-gripping polyester mesh used to repair hernias. Of its 352 reports, 331 describe injuries, 18 describe malfunctions, and 3 mention deaths. Most mention pain or tissue injury, and many describe hernias returning, adhesions or emotional changes. 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
- 352
- Deaths reported
- 3
- Injuries reported
- 331
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 352 adverse event reports that list this exact device (DI 10884521177680), received between Oct 25, 2016 and May 15, 2026 — classified as 3 deaths, 331 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (139 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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem337
- Mechanics Altered139
- Migration or Expulsion of Device71
- Insufficient Device Problem Information26
- Patient Device Interaction Problem23
- Material Split, Cut or Torn19
- Material Deformation11
- Material Integrity Problem11
Patient problems
- Pain272
- Hernia262
- Unspecified Tissue Injury235
- Injury170
- Adhesion(s)160
- Emotional Changes149
- Scar Tissue138
- Inflammation105
Recent adverse event reports
The 25 most recent of 352 reports, in the reporter's own words as published by the FDA.
DeathMay 15, 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, RECURRENCE, DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.
Patient problems: Distress; Hernia; Nerve Damage; Pain; Unspecified Tissue Injury
MAUDE report 25186440 ↗InjuryMay 12, 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 RECURRENCE, PAIN, SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, HERNIA REPAIR WITH NEW MESH.
Patient problems: Hernia; Pain; Unspecified Tissue Injury
MAUDE report 25153185 ↗MalfunctionApr 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD A LEFT INGUINAL HERNIA (DIRECT APPROACH WITH PROSTHESIS). UPON FOLLOW-UP, THE PATIENT HAD A LITTLE PAIN. THE ABDOMEN WAS SUPPLE AND PAINLESS. THE PATIENT RETURNED HOME THE SAME DAY, SIMPLE ANALGESICS WERE PRESCRIBED AND LOCAL CARE EVERY 48 HOURS WAS DONE. ON (B)(6) 2022, THE PATIENT HAD VARIOUS AILMENTS, INTESTINAL AND BLADDER PROBLEMS. BACK PAIN, LIMITED MOVEMENTS, AND NO LONGER BEING ABLE TO DO SPORTS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Back pain; Bladder Dysfunction; Pain
MAUDE report 24921411 ↗InjuryApr 10, 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 PAIN, NERVE DAMAGE, RECURRENCE, SWELLING, NERVE PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.
Patient problems: Discomfort; Hernia; Nerve Damage; Pain; Swelling/ Edema; Unspecified Tissue Injury
MAUDE report 24840185 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE CLINICAL STUDY, POSTOPERATIVE TO A LEFT INGUINAL HERNIA REPAIR, THE PATIENT HAD REPETITIVE AND INTENSE PAIN. MEDICATIONS SUCH AS DOLIPRANE, TRAMADOL, GABAPENTIN, VERSATIS PATCH, PREGABALIN, LAROXYL, CYMBALTA, ORAMORPH, AND AMITRIPTYLINE WERE INEFFECTIVE. ON (B)(6) 2025, THE PATIENT WAS HOSPITALIZED FOR A LEFT INGUINAL HERNIA AND OLD PROSTHESIS EXCISION USING THE LICHTENSTEIN TECHNIQUE. THE IMMEDIATE POST-OPERATIVE FOLLOW-UP WAS SIMPLE WITH RESUMPTION OF A NORMAL, WELL-TOLERATED DIET, ACCORDING TO THE PROTOCOL OF IMPROVED REHABILITATION AFTER SURGERY. THE SCARS WERE CLEAN AND NON-INFLAMMATORY. GIVEN THE FAVORABLE DEVELOPMENT, THE PATIENT WAS ALLOWED TO RETURN HOME THE SAME DAY. PATIENT FOLLOWED AT THE PAIN CENTER FOR PLACEMENT OF A QUTENZA PATCH. THE PATIENT UNDERWENT AN ULTRASOUND, A COMPUTED TOMOGRAPHY (CT) SCAN AND AN ELECTROMYOPGRAPHY (EMG). THERE WAS NO RECURRENCE, AND NO NERVE DAMAGE. THE PATIENT HAD AN INTOLERANCE WITHOUT EFFECTIVE TREATMENTS WITH AN ALTERED QUALITY OF LIFE. THE PATIENT WAS THEN SCHEDULED FOR A REMOVAL OF THE PLAQUE UNDER GENERAL ANESTHESIA AND A WALL CLOSURE BY SUTURE. THERE WAS NO HERNIA, YET THERE WAS A SMALL LIPOMA IN THE SUPERFICIAL INGU
Patient problems: Hernia; Pain; Unintended Radiation Exposure
MAUDE report 24827797 ↗InjuryApr 2, 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 RECURRENCE, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION.
Patient problems: Hernia; Pain; Unspecified Tissue Injury
MAUDE report 24768590 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING A SURGICAL PROCEDURE IN (B)(6) 2019 FOR AN UMBILICAL HERNIA AND DIASTASIS, A HIGH EVENTRATION OCCURRED, INDICATING RECURRENCE OR NEW HERNIATION AFTER THE INITIAL SURGERY, AND IT WAS ALLEGED THAT THE FIRST PROSTHESES FAILED. A SECOND OPERATION WAS PERFORMED IN (B)(6) 2020 WITH IMPLANTATION OF MESH. SINCE THESE PROCEDURES, THE INDIVIDUAL EXPERIENCED CHRONIC AND VERY FREQUENT STOMACH PAIN, DIGESTION PROBLEMS, ACCUMULATED FATIGUE, INABILITY TO RESUME SPORTS AND NORMAL LIFE, HEART PROBLEMS WITH TACHYCARDIA, SUSPICION OF MYOCARDITIS AND/OR PERICARDITIS, SYMPTOMS SIMILAR TO A HEART ATTACK, LUNG PROBLEMS, HOSPITALIZATION, AND ONGOING MONITORING OF THE LUNGS. NUMEROUS MEDICAL TESTS WERE CONDUCTED, WHICH REVEALED NO SPECIFIC FINDINGS, AND A DIAGNOSIS OF "LONG COVID" WAS MADE. THE INDIVIDUAL ALSO REPORTED PSYCHOLOGICAL IMPACT AND CONSEQUENCES ON MORALE.
Patient problems: Abdominal Pain; Fatigue; Hernia; Tachycardia; Unspecified Gastrointestinal Problem; Unspecified Heart Problem; Unspecified Respiratory Problem
MAUDE report 24637853 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, POST-OPERATIVELY OF A LEFT INGUINAL HERNIA, THE PATIENT WAS REHOSPITALIZED DUE TO SEVERE LEFT LEG PAIN SINCE THE INSERTION OF THE INGUINAL PLATE. THE PATIENT ALSO EXPERIENCED TIREDNESS, STOMACH PAIN, TESTICULAR PAIN, AND BACK PAIN. THE PATIENT WAS REFERRED TO A SPECIALIST THE PATIENT WAS GIVEN ANALGESICS, MOTOR PHYSIOTHERAPY, AND A PRESCRIPTION TO CARRY OUT A SPINE SCAN ON AN OUTPATIENT BASIS.
Patient problems: Abdominal Pain; Back pain; Extreme Exhaustion; Pain
MAUDE report 24556280 ↗InjuryJan 30, 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. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Abdominal Distention; Adhesion(s); Distress; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 24226120 ↗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 24121432 ↗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 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: Emotional Changes; Pain; Unspecified Tissue Injury
MAUDE report 24119127 ↗InjuryDec 30, 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 UMBILICAL AND BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, SEROMA, NON-HEALING ABDOMINAL WOUND, ABDOMINAL DISTENTION, ABSCESS, NUMBNESS IN ABDOMEN AND GROIN, DEFECTIVE MESH, FAILURE OF MESH, CHRONIC WOUND, ADHESIONS, INFECTION, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REMOVAL OF MESH, EXCISION OF CHRONIC WOUND, DEBRIDEMENT OF ABDOMINAL SKIN, WOUND VAC, LYSIS OF ADHESIONS.
Patient problems: Abdominal Distention; Abscess; Adhesion(s); Emotional Changes; Hernia; Impaired Healing; Inflammation; Numbness; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 23926658 ↗InjuryDec 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 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; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 23809395 ↗InjuryDec 3, 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, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.
Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 23707017 ↗InjuryNov 7, 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 bilateral inguinal hernia. It was reported that after implant, the patient experienced emotional distress, hernia recurrence, pain, suffering, <(>&<)> nerve damage. Post-operative patient treatment included revision surgery, mesh removal, hernia repair with mesh, <(>&<)> hernia repair.
Patient problems: Distress; Hernia; Nerve Damage; Pain; Unspecified Tissue Injury
MAUDE report 23500486 ↗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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, ADHESIONS, PAIN, RECURRENCE, DYSPAREUNIA, ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, AND HERNIA REPAIR WITH NEW MESH.
Patient problems: Abdominal Pain; Adhesion(s); Distress; Dyspareunia; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 23304078 ↗InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 PAIN, RECURRENCE, MESH FAILURE, EMOTIONAL HARM AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH.
Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 23089960 ↗InjuryAug 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, AND SCAR TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Adhesion(s); Hernia; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 22901131 ↗DeathJul 30, 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 EMOTIONAL DISTRESS, ADHESIONS, BOWEL OBSTRUCTION, PERFORATION, PAIN, LOSS OF APPETITE, CORE MUSCLE WEAKNESS, CONSTIPATION, RESPIRATORY FAILURE, HYPOXIA, ELECTROLYTE IMBALANCE, DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, LYSIS OF ADHESIONS, MESH REVISION, HOSPICE CARE. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.
Patient problems: Adhesion(s); Constipation; Decreased Appetite; Distress; Electrolyte Imbalance; Hypoxia; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Perforation; Respiratory Failure; Unspecified Tissue Injury
MAUDE report 22668043 ↗InjuryJul 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Abdominal Pain; Bacterial Infection; Bruise/Contusion; Distress; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Nerve Damage; Pain; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 22376328 ↗InjuryJun 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND ILIOINGUINAL NEUROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, MEDICATION AND EXCISION OF ILIOINGUINAL NEUROMA.
Patient problems: Hernia; Nodule; Unspecified Tissue Injury
MAUDE report 22341975 ↗InjuryApr 18, 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, ADHESIONS, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.
Patient problems: Adhesion(s); Emotional Changes; Hernia; Nausea; Nerve Damage; Pain; Scar Tissue; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury; Vomiting
MAUDE report 21868119 ↗MalfunctionApr 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN INGUINAL HERNIA REPAIR BY LICHTENSTEIN TECHNIQUE, BEFORE USING THE DEVICE TO THE PATIENT AND WHEN THE STERILE PACKAGING OF THE MESH WAS OPENED, THE REMOVABLE PART OF THE PROSTHESIS WAS COMPLETELY DETACHED, ALTHOUGH IT WAS SUPPOSED TO BE FIXED ON ONE SIDE. THE PROSTHESIS WAS SET ASIDE, AND ANOTHER PROSTHESIS OF THE SAME BRAND AND MODEL WAS PUT IN PLACE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21860719 ↗InjuryMar 19, 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. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.
Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 21646280 ↗InjuryMar 6, 2025Mechanics Altered; Adverse Event Without Identified Device or Use 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.
Patient problems: Adhesion(s); Emotional Changes; Hernia; Nerve Damage; Pain; Unspecified Tissue Injury
MAUDE report 21540645 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.