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Parietex TEC1510Recalls & reported problems

Sofradim Production · Hydrophilic 2-Dimensional Mesh,Polyester · Class 2 · Implant

Quick summary

This Sofradim Parietex polyester hernia mesh has 86 adverse event reports: 84 injuries and 2 deaths. The reports mostly describe hernias coming back, pain, infection, and mesh migration, often requiring revision surgery. Many reports note that a patient's attorney alleged a deficiency in the device. 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
86
Deaths reported
2
Injuries reported
84
Recalls naming it
0

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10884521180253), received between Oct 10, 2017 and Jun 4, 2026 — classified as 2 deaths, 84 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (25 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: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem86
  • Migration or Expulsion of Device25
  • Mechanics Altered15
  • Patient Device Interaction Problem14
  • Material Deformation3
  • Detachment of Device or Device Component2
  • Insufficient Device Problem Information2
  • Material Integrity Problem2

Patient problems

  • Pain76
  • Unspecified Tissue Injury70
  • Hernia60
  • Adhesion(s)46
  • Injury45
  • Unspecified Infection34
  • Inflammation31
  • No Code Available28

Recent adverse event reports

The 25 most recent of 86 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, SUFFERING AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH AND MESH REVISION.

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

    MAUDE report 25394919 ↗
  • InjuryApr 3, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, PAIN, SPERMATIC CORD INVOLVEMENT, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, TESTICLE REMOVED.

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

    MAUDE report 24781596 ↗
  • InjuryJul 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 EMOTIONAL DISTRESS, ADHESIONS, INFECTION, PAIN, LESIONS, HEMATURIA, INFLAMMATION, LEFT LEG MUSCLE WEAKNESS, MASS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, CYSTOURETHROSCOPY WITH PLACEMENT URETERAL STENT, MESH REMOVAL, CT-GUIDED BIOPSY, MRI, MEDICATION, DIAGNOSTIC LAPAROSCOPY.

    Patient problems: Adhesion(s); Distress; Hematuria; Inflammation; Localized Skin Lesion; Muscle Weakness/Atrophy; Nodule; Pain; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 22395077 ↗
  • InjuryJul 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

    Patient problems: Adhesion(s); Distress; Hematuria; Inflammation; Localized Skin Lesion; Muscle Weakness/Atrophy; Nodule; Pain; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 22395072 ↗
  • InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT WAS TREATED IN (B)(6) 2020 FOR A HERNIA IN A THIGH MUSCLE USING A MESH. AFTER A FEW MONTHS POST-TREATMENT, THE PATIENT EXPERIENCED ITCHING, A BURNING SENSATION, PATCHES, AND A RASH. TESTS CONDUCTED BY AN ALLERGIST CONFIRMED AN ALLERGIC REACTION. THE PATCH WAS REMOVED IN 2023.

    Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Rash

    MAUDE report 21909478 ↗
  • 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABSCESS, INFECTION, PAIN, SUFFERING, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, ULTRASOUND-GUIDED ASPIRATION OF INFECTION/ABSCESS, INCISION AND DRAINAGE, DRAIN PLACEMENT.

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

    MAUDE report 21185615 ↗
  • InjuryNov 8, 2023Migration 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 THE IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL INTERVENTION.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Distress; Fluid Discharge; Impaired Healing; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 18094796 ↗
  • InjuryOct 24, 2023Material 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, MESH BULGING, AND PERMANENT PARTIAL NUMBNESS AT SITE OF MESH REPAIR. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

    MAUDE report 17999481 ↗
  • InjuryJun 28, 2023Adverse 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 RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

    Patient problems: Hernia; Pain; Unspecified Tissue Injury

    MAUDE report 17219520 ↗
  • InjuryMar 31, 2023Adverse 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 THE IMPLANT, THE PATIENT EXPERIENCED ACUTE CHRONIC PAIN, HERNIA RECURRENCE, INFLAMMATION, ADHESIONS, SEROMA AND FREQUENT URINATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION AND EXPLANT SURGERY.

    Patient problems: Adhesion(s); Hernia; Inflammation; Pain; Seroma; Unspecified Tissue Injury; Urinary Frequency / Polyuria

    MAUDE report 16659771 ↗
  • InjuryMar 16, 2023Migration 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 SPIGELIAN HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, CHRONIC PAIN, MESH MIGRATION, MESH FOLDED, AND ALLERGIC REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

    Patient problems: Adhesion(s); Hernia; Hypersensitivity/Allergic reaction; Pain; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 16554705 ↗
  • InjuryMar 16, 2023Adverse 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 AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REVISION SURGERY, AND HERNIA REPAIR WITH NEW MESH.

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

    MAUDE report 16554273 ↗
  • InjuryMar 16, 2023Adverse 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 AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REVISION SURGERY, AND HERNIA REPAIR WITH NEW MESH.

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

    MAUDE report 16554267 ↗
  • InjuryJan 9, 2023Adverse 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, ADHESION, AND NUMBNESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

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

    MAUDE report 16126726 ↗
  • InjuryJun 16, 2022Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, ADHESIONS, PAIN, AND SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

    Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Cyst(s); Fatigue; Fever; Hematoma; Hernia; Inflammation; Nodule; Pain; Purulent Discharge; Scar Tissue; Seroma; Sleep Dysfunction; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vomiting

    MAUDE report 14718383 ↗
  • InjuryJun 16, 2022Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, ADHESIONS, PAIN, AND SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

    Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Cyst(s); Fatigue; Fever; Hematoma; Hernia; Inflammation; Nodule; Pain; Purulent Discharge; Scar Tissue; Seroma; Sleep Dysfunction; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vomiting

    MAUDE report 14718293 ↗
  • InjuryApr 8, 2022Migration 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 INFECTION, PAIN, SCARRING, OPEN DRAINING WOUND, AND MESH DETACHMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

    Patient problems: Fluid Discharge; Impaired Healing; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 14058244 ↗
  • InjuryOct 18, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESION, NECROSIS, FATTY LESION, PAIN, BULGING, URINARY SYMPTOMS, HARD LUMP, CORD LIPOMA, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND BIOPSY.

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

    MAUDE report 12648910 ↗
  • InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, THERE WAS RECURRENT LEFT FEMORAL HERNIA THAT HAD TO BE REPAIRED. THE BILATERAL LAPAROSCOPIC EXTRAPERITONEAL MESH HERNIA REPAIR AND HAS FAILED. THERE WAS FORMATION OF ADHESIONS IN THE INGUINAL REGION AND ONSET OF CEASELESS CHRONIC PAIN WHICH LED TO COMPLEX REGIONAL SYNDROME (CRPS).

    Patient problems: Adhesion(s); Pain

    MAUDE report 12392443 ↗
  • InjuryAug 13, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ABDOMINAL PAIN, ADHESIONS, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY AND HERNIA REPAIR WITH MESH.

    Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Hernia; Inflammation; Muscle Weakness/Atrophy; Nodule; Pain; Unspecified Tissue Injury

    MAUDE report 12318804 ↗
  • InjuryJul 29, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED A HEMATOMA, HERNIA RECURRENCE, MESH FAILURE, EMOTIONAL CHANGES, DISCOMFORT, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, MEDICATION, HERNIA REPAIR WITH NEW MESH.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Fluid Discharge; Hematoma; Hernia; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 12247010 ↗
  • DeathJul 23, 2021Migration or Expulsion of Device; Detachment of Device or Device Component; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; Detachment of Device or Device Component; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF RIGHT AND LEFT INGUINAL HERNIA REPAIR. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, RECTAL BLEEDING, DIVERTICULITIS, MESH BROKEN INTO PIECES, PIECES MIGRATED, FAILURE OF MESH, INJURY, BOWEL PERFORATION, INFECTION, PAIN, EMOTIONAL PAIN, HARM, DISABILITY, DISFIGUREMENT, MENTAL ANGUISH, AND DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF PIECES OF MESH, ANTIBIOTICS, AND HOSPITALIZATIONS. INFORMATION RECEIVED INDICATES THE PATIENT IS NOW DECEASED, DUE TO INFECTION FROM THE HERNIA MESH.

    Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bowel Perforation; Deformity/ Disfigurement; Emotional Changes; Failure of Implant; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 12219709 ↗
  • InjuryJul 23, 2021Adverse 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANTS, THE PATIENT EXPERIENCED INFECTION/INFECTED MESH, DRAINING FISTULA, CHRONIC DRAINING ABDOMINAL WALL SINUSES, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ABDOMINAL WASHOUT, SKIN CLOSURE, LAPAROTOMY, AND REMOVAL OF MESH.

    Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Pain; Perforation; Seroma; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 12217386 ↗
  • InjuryJul 15, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DESIGN DEFECT, SMALL BOWEL INVOLVEMENT, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL REPAIR, AND PARTIAL MESH REMOVAL.

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

    MAUDE report 12175763 ↗
  • InjuryJun 25, 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 LEFT FLANK HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, DENSE ADHESIONS, ABSCESS, AND SEVERE PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED NEED FOR ADDITIONAL SURGICAL INTERVENTION, AND REVISION SURGERY.

    Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Heartburn/Indigestion; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Obstruction/Occlusion; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 12067859 ↗

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.