Parietene PPM1515X3Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10884521213838), received between Dec 15, 2017 and Aug 11, 2026 — classified as 46 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanics Altered” (18 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 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 an inguinal hernia. It was reported that after the implant, the patient experienced abdominal pain, mesh migration, pain/suffering, severe emotional distress, disability, impairment, loss of enjoyment of life, loss of care, loss of comfort, defective mesh, mental pain, distress, and recurrence. Concomitant device: Protacker.

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

  MAUDE report 50211968 ↗
• InjuryFeb 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 bilateral inguinal hernias. It was reported that after implant, the patient experienced recurrence, pain, suffering and emotional distress. Post-operative patient treatment included revision surgery, mesh revision and hernia repair with mesh.

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

  MAUDE report 24393849 ↗
• InjuryFeb 13, 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 AND VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, FISTULA, INFECTION, PAIN, SUFFERING, SCAR, DRAINING SINUS, SEROMA, AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND DEBRIDEMENT, EXCISION OF UMBILICUS, CLOSURE/REPAIR OF HERNIA, EXCISION OF SCAR AND SINUS, INCISION AND DRAINAGE, ABDOMINAL WALL RECONSTRUCTION AND MESH REMOVAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Fistula; Fluid Discharge; Hernia; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 24338256 ↗
• InjuryFeb 13, 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 AND VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, FISTULA, INFECTION, PAIN, SUFFERING, SCAR, DRAINING SINUS, SEROMA, AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, REVISION SURGERY, WOUND DEBRIDEMENT, EXCISION OF UMBILICUS, CLOSURE/REPAIR OF HERNIA, EXCISION OF SCAR AND SINUS, INCISION AND DRAINAGE, ABDOMINAL WALL RECONSTRUCTION AND MESH REMOVAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Fistula; Fluid Discharge; Hernia; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 24338248 ↗
• InjuryNov 3, 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 EMOTIONAL DISTRESS, RECURRENCE, MESH MIGRATION, PAIN, ADHESION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 23454060 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A RIGHT DIAPHRAGMATIC HERNIA REPAIR VIA POLYPROPYLENE MESH IN 2023. THE PATIENT HAD PAIN AND AFFECTION OF BREATHING DIRECTLY AFTER. THE PATIENT GOT A NERVE CONDUCTION STUDY IN THE SAME YEAR THAT SHOWED A RIGHT PHRENIC NERVE INJURY CAUSING PARTIAL PARALYSIS OF THE RIGHT PHRENIC NERVE, CAUSING THE PATIENT UNILATERAL DIAPHRAGMATIC PARALYSIS. IN (B)(6) 2024, THE PATIENT BEGAN EXPERIENCING A COUGH WITH THICK GREEN SPUTUM. THE CULTURE SHOWED PSEUDOMONAS, AND IT GOT MULTIPLE ANTIBIOTICS WITHOUT ANY IMPROVEMENTS. A BRONCHOSCOPY WITH BRONCHOALVEOLAR LAVAGE AND CULTURE SHOWED A STAPHYLOCOCCUS PSEUDINTERMEDIUS. THE PATIENT HAD ANTIBIOTICS DIRECTED, BUT NO USE. IT HAS BEEN A YEAR SINCE THE PATIENT GOT A COUGH AND THICK GREEN SPUTUM THAT IS STILL ONGOING DAILY UNTIL THIS MOMENT.

  Patient problems: Cough; Dyspnea; Nerve Damage; Pain; Paralysis; Unspecified Infection

  MAUDE report 22607939 ↗
• InjuryJun 30, 2025Degraded; Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Degraded; Migration or Expulsion of Device; Material Deformation; Mechanics Altered; 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 RECURRENT VENTRAL HERNIA HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, WEAK AND BULGY MESH, DEFECTS THROUGH THE MESH, PAIN, RECURRENCE, ADHESIONS, AND MULTIPLE SWISS CHEESE DEFECTS.

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

  MAUDE report 22362301 ↗
• InjuryJun 27, 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 AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22350665 ↗
• InjuryJun 23, 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 SEROMA, ALLERGIC REACTION, PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Hernia; Hypersensitivity/Allergic reaction; Pain; Seroma; Unspecified Tissue Injury

  MAUDE report 22310024 ↗
• InjuryApr 14, 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 AN EPIGASTRIC INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EXPOSED MESH, PAIN, INFECTION, INFLAMMATION, ADHESIONS, OBSTRUCTION, PERFORATION, ABSCESS, DRAINING SINUS TRACT, SEROSAL TEARING, ENTEROTOMIES, BILIOUS DRAINAGE, ISCHEMIC ENTEROPATHY, SUBMUCOSAL EDEMA, SUBSEROSAL CONGESTION, SCARRING, PURULENT FLUID FROM WOUND, FOREIGN BODY REACTION, GRANULATION TISSUE, FEVER, NAUSEA, VOMITING, WEIGHT LOSS, CRAMPING, HEMATOMA, AND MENTAL STRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH, MEDICATION, AND SMALL BOWEL RESECTION.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cramp(s) /Muscle Spasm(s); Distress; Fever; Fluid Discharge; Foreign Body Reaction; Hematoma; Impaired Healing; Inflammation; Ischemia; Nausea; Obstruction/Occlusion; Pain; Perforation; Purulent Discharge; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 21837174 ↗
• InjuryMar 31, 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: Adhesion(s); Distress; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 21731819 ↗
• MalfunctionJul 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIORRHAPHY, WHILE FIXING THE MESH, IT BROKE AT A POINT INTENDED TO SECURE IT WITHIN THE PATIENT. A NEW MESH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761679 ↗
• InjuryApr 3, 2024Adverse 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, OBSTRUCTIONS, INFECTION, FISTULAS, SEROMA, PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 19033778 ↗
• InjuryFeb 27, 2024Material 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 THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MESH BALLOONED OUT INTO HERNIA SAC, RECURRENCE, ADHESIONS, NUMBNESS, ISSUES WITH BOWEL MOVEMENTS, <(>&<)> DISCOMFORT DUE TO PRESSURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, MESH RESECTION, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 18793239 ↗
• InjuryJan 16, 2024Adverse 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 A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ALLERGIC REACTION, SEROMA, PERFORATION, BOWEL ISSUES, CONTINUOUS DISCOMFORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Pain; Perforation; Seroma; Unspecified Tissue Injury

  MAUDE report 18519655 ↗
• InjuryAug 4, 2023Mechanics 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, ABDOMINAL PAIN, ADHESIONS, RECURRENCE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

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

  MAUDE report 17461585 ↗
• InjuryNov 18, 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 ABDOMINAL PAIN, PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, SEROMA, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, MEDICATION, USE OF DRAINS, WOUND VAC, AND PROLONGED USE OF IV ANTIBIOTICS.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Hernia; Inflammation; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15825463 ↗
• InjuryNov 8, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, WOUND, DESEROSALIZATION, SEROMA, FLUID COLLECTION, PAIN, INFLAMMATORY RESPONSE, DISCOMFORT, MENTAL ANGUISH, IMPAIRMENT OF DAILY LIVING, DEVICE DEFECTIVE, SUFFERING, EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, & LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, WOUND VAC, HERNIA REPAIR WITH MESH, FLUID COLLECTION ASPIRATION, & INCISION AND DRAINAGE OF ABDOMINAL WALL WOUND.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Discomfort; Distress; Emotional Changes; Fibrosis; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Nerve Damage; Pain; Seroma; Sexual Dysfunction; Unspecified Tissue Injury

  MAUDE report 15756336 ↗
• InjuryJul 29, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, MENTAL PAIN, SUFFERING, GIANT CELL REACTION, DEFECTIVE DEVICE, MESH FAILURE, AND SCARRING.

  Patient problems: Emotional Changes; Foreign Body Reaction; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 15131555 ↗
• InjuryJul 25, 2022Migration 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MESH FAILURE, MESH MIGRATION, RECURRENCE, SEROMA, ABSCESS, PAIN, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, MENTAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15094649 ↗
• InjuryJun 23, 2022Migration 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, PAIN, SUFFERING, INFLAMMATION, ADHESIONS, MESH MIGRATION, MENTAL PAIN, DISABILITY, IMPAIRMENT, MESH FAILURE, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 14790558 ↗
• InjuryDec 19, 2021Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Mechanics Altered; 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MESH FAILURE, ADHESIONS, BOWEL OBSTRUCTION, HERNIA RECURRENCE, PAIN, INFLAMMATION, BOWEL NECROSIS, FISTULA, AND BOWEL EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, BOWEL RESECTION, BOWEL DESEROSALIZAION, LYSIS OF ADHESIONS, BONE ANCHORS, WOUND VAC, RIGHT/LEFT EXTERNAL OBLIQUE MUSCLE FLAP, THORACOLUMBAR PERFORATOR FASCIO CUTANEOUS FLAP, AND ENTEROTOMY.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Erosion; Fistula; Hernia; Inflammation; Necrosis; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 13040564 ↗
• InjuryOct 24, 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 GROIN PAIN AND RECURRENT HERNIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 12687016 ↗
• 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, AND 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, MESH REMOVAL, AND MESH REVISION.

  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; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 12416401 ↗
• InjuryJul 15, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS TO BOWEL, ADHESIONS, MESH DETACHMENT, EMOTIONAL DISTRESS, SEVERE AND CHRONIC PAIN AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, BOWEL RESECTION AND SURGERY TO REMOVE MESH.

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

  MAUDE report 12178724 ↗