Parietex PNP8X3Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 20884521176437), received between Oct 10, 2017 and May 1, 2026 — classified as 85 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (34 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 85 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 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 MEDICAL TREATMENT.

  Patient problems: Emotional Changes; Pain; Unspecified Tissue Injury

  MAUDE report 25057573 ↗
• InjuryApr 16, 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 CLOT, ADHESIONS, RECURRENCE, PAIN, SUFFERING AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY, HERNIA REPAIR WITH NEW MESH, REMOVAL OF PORTION OF MESH, REMOVAL OF OLD CLOT.

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

  MAUDE report 24899971 ↗
• InjuryApr 11, 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 ADHESIONS, RECURRENCE, PAIN, SUFFERING, MESH FAILURE, EMOTIONAL HARM, DISCOMFORT, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL INTERVENTION, HERNIA REPAIR, MESH REVISION AND LYSIS OF ADHESIONS.

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

  MAUDE report 24847549 ↗
• InjuryApr 3, 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 RECURRENCE, PAIN AND SUFFERING.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 24780088 ↗
• InjuryMar 24, 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, INFLAMMATION, NERVE DAMAGE, SCARRING, FIBROSIS, NUMBNESS, MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY AND MEDICATION.

  Patient problems: Fibrosis; Hernia; Inflammation; Nerve Damage; Numbness; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 21679169 ↗
• InjuryFeb 24, 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, INFECTION, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND INCISION AND DRAINAGE, WOUND VAC, AND MEDICATION. IT WAS NOTED THAT NO MESH WAS SEEN DURING CHEST WALL EXPLORATION OR POSTPROCEDURAL WOUND INFECTION.

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

  MAUDE report 21454124 ↗
• InjuryDec 20, 2024Adverse 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 ADHESIONS, PAIN, NERVE DAMAGE, SPERMATIC CORD INVOLVEMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 20995145 ↗
• InjuryNov 7, 2024Adverse 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 INFECTION, NERVE DAMAGE, SWELLING, SEXUAL DYSFUNCTION, SLEEP DISTURBANCES, PAIN, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, HOSPITALIZATION.

  Patient problems: Hernia; Nerve Damage; Pain; Sexual Dysfunction; Sleep Dysfunction; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20631834 ↗
• InjuryApr 30, 2024Adverse 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.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 19217119 ↗
• InjuryApr 2, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, ABDOMINAL BULGE, ADHESIONS TO THE PERITONEUM, RECURRENCE, MESHOMA, SCARRING, INFLAMMATION, NERVE ENTRAPMENT, FIBROSIS, NERVE DAMAGE, MESH MIGRATION, FAILURE OF MESH, PERMANENT IMPAIRMENT, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE, AND WADDED UP MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, <(>&<)> HERNIA REPAIR WITH MESH.

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

  MAUDE report 19021168 ↗
• InjuryJan 17, 2024Adverse 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA, INGUINODYNIA, PAIN THAT INTERFERES WITH DAILY LIVING, AND TINGLING OF THING OR SCROTUM. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Discomfort; Hernia; Pain; Paresthesia; Unspecified Tissue Injury

  MAUDE report 18531076 ↗
• InjuryNov 3, 2023Degraded; 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 IMPLANT, THE PATIENT EXPERIENCED MESH DISINTEGRATION/FRAYING, PAIN, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND REMOVAL OF MESH.

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

  MAUDE report 18067055 ↗
• InjuryOct 27, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, FISTULA, ABSCESS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, TAKE DOWN OF FISTULA, ABSCESS DRAINED.

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

  MAUDE report 18023050 ↗
• InjuryJun 30, 2023Migration 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, MESH MIGRATION, RECURRENCE, INFLAMMATION, INFECTION, NERVE DAMAGE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 17238518 ↗
• InjuryJun 30, 2023Migration 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, MESH MIGRATION, RECURRENCE, INFLAMMATION, INFECTION, NERVE DAMAGE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

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

  MAUDE report 17238505 ↗
• InjuryJun 2, 2023Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, INFLAMMATION, NERVE DAMAGE, SCAR TISSUE, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

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

  MAUDE report 17052634 ↗
• InjuryMay 30, 2023Migration 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, INFLAMMATION, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR.

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

  MAUDE report 17020673 ↗
• InjuryFeb 22, 2023Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INGUINAL PAIN, SWELLING, SCARRING, SUFFERING, CHRONIC GROIN PAIN, MESH PROTRUSION, DIMINISHED QUALITY OF LIFE, TEAR IN THE PERITONEUM, MENTAL ANGUISH, MESH FAILURE, DEFECTIVE DEVICE, DISABILITY, LOSS OF ENJOYMENT OF LIFE, PAIN, EMOTIONAL DISTRESS, MENTAL PAIN, RECURRENCE, ADHESIONS, SCAR TISSUE, INFLAMMATION, DISCOMFORT, AND IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, AND LAP REPAIR OF RECURRENT HERNIA WITH NEW MESH.

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

  MAUDE report 16423531 ↗
• InjuryFeb 14, 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 DISCOMFORT, FULLNESS, FIRMNESS, SCARRING, CAPSULAR HYPERTROPHY, FLUID BETWEEN SYMPHYSIS AND TENDON, PARTIAL AVULSION OF RECTUS ABDOMINIS/RECTUS ABDOMINIS APONEUROSIS, PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, LOSS OF ENJOYMENT OF LIFE, LOSS OF ABILITY TO PARTICIPATE IN REGULAR/NORMAL ACTIVATES, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED PHYSIOTHERAPY, PAIN MEDICATIONS, CT, REPARATIVE SURGERY, HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS, MEDICATION, THERAPY, AND REHABILITATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Hernia; Inflammation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16375224 ↗
• InjuryDec 6, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED DEVICE DEFECTIVE, PAIN, MENTAL PAIN, SUFFERING, DISABILITY, PERMANENT IMPAIRMENT, <(>&<)> LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

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

  MAUDE report 15926170 ↗
• InjurySep 8, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, HEMATOMA, SWELLING, AND INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Hematoma; Hernia; Inflammation; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15384947 ↗
• InjuryOct 13, 2021Adverse 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 THE IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, LOSS OF ENJOYMENT OF LIFE, LOSS OF ABILITY TO PARTICIPATE IN REGULAR/NORMAL ACTIVATES, AND HERNIA RECURRENCE,. POST-OPERATIVE PATIENT TREATMENT INCLUDED REPARATIVE SURGERY, HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS, MEDICATION, THERAPY, AND REHABILITATION.

  Patient problems: Emotional Changes; Hernia; Inflammation; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12623828 ↗
• InjuryOct 8, 2021Migration 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESHOMA, HEMATOMA, DISCOMFORT, PAIN, AND MESH SHRINKAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND ASPIRATION/EVACUATION OF HEMATOMA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hematoma; Pain; Unspecified Tissue Injury

  MAUDE report 12598402 ↗
• InjurySep 9, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 12450825 ↗
• InjurySep 9, 2021Migration 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 RIGHT GROIN HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, IMPLANT FAILURE, MESH MIGRATION, SCARRING, GROIN PAIN, ADHESIONS, AND MESH CONTRACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY AND ADDITIONAL SURGERY.

  Patient problems: Adhesion(s); Failure of Implant; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 12448226 ↗