Parietex TECT1510ARRecalls & reported problems

Summary

The FDA's MAUDE database contains 283 adverse event reports that list this exact device (DI 10884521180017), received between Sep 15, 2017 and Aug 20, 2026 — classified as 2 deaths, 278 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (101 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 283 reports, in the reporter's own words as published by the FDA.

• DeathAug 20, 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, death. Post-operative patient treatment included revision surgery. Information received indicates the patient is deceased. No information was provided regarding the circumstances of expiration.

  Patient problems: Distress; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 50356531 ↗
• MalfunctionMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVE TO AN INGUINAL HERNIA TREATMENT, THE PATIENT EXPERIENCED DISABLING PAIN IN THE STOMACH AND OTHER PARTS OF THE BODY.

  Patient problems: Pain

  MAUDE report 25213634 ↗
• InjuryMay 18, 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, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 25204261 ↗
• InjuryMay 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, ABSCESS, ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 25186716 ↗
• InjuryMay 6, 2026Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ABSCESS, INFECTION, PAIN, SUFFERING AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY LAPAROTOMY, HERNIA REPAIR WITH OMENTAL PATCH, WIDE LOCAL RESECTION OF ABSCESS AND REMOVAL OF MESH.

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

  MAUDE report 25095639 ↗
• InjuryApr 7, 2026Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A BILATERAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, EMOTIONAL HARM, DISCOMFORT, RECURRENCE, CHRONIC PAIN, BULGE IN GROIN, LIFTING WEIGHT RESTRICTION, <(>&<)> CORD LIPOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, MEDICATION, <(>&<)> EXCISION OF CORD LIPOMA.

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

  MAUDE report 24802638 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING SURGERY FOR BILATERAL INGUINAL HERNIAS WITH IMPLANTATION OF TWO MESH, THE PATIENT EXPERIENCED CONSTANT PAIN THAT COULD NOT BE RELIEVED, PERSISTENT MODERATE TO SEVERE PAIN ON BOTH SIDES RADIATING TO THE TESTICLES, TENSION, TIGHTNESS, BURNING SENSATIONS, INABILITY TO SIT FOR LONG PERIODS, INABILITY TO CARRY A SMALL LOAD, INABILITY TO WEAR A BELT, AND INABILITY TO HOLD BACK URINATION. THE PAIN WAS DESCRIBED AS UNBEARABLE, REQUIRING EMERGENCY ROOM VISITS, AND RESULTED IN A SIGNIFICANT REDUCTION IN ACTIVITIES, IMPACTING FAMILY AND SOCIAL LIFE. ONGOING PAIN MANAGEMENT INCLUDED A NEUROPATHIC PAIN AGENT, A TRICYCLIC ANTIDEPRESSANT, AN ANXIOLYTIC (BENZODIAZEPINE), AND TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) THERAPY. MULTIPLE SURGEONS REFUSED TO RE-OPERATE. SEVERAL ULTRASOUNDS, SCANS, MRIS (MAGNETIC RESONANCE IMAGINE SCANS), AND BLOOD TESTS WERE CONDUCTED, ALL SHOWING NO ABNORMALITY.

  Patient problems: Burning Sensation; Discomfort; Pain; Unintended Radiation Exposure

  MAUDE report 24551400 ↗
• InjuryDec 12, 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, MESH MIGRATION, PAIN, ABSCESS, ADHESIONS, RECURRENCE, INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, MEH REVISION.

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

  MAUDE report 23794493 ↗
• InjuryOct 28, 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 RECURRENCE, ADHESIONS, OPEN DRAINING WOUND, PAIN, DISCOMFORT, PRESSURE AND PHYSICAL LIMITATIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL REMOVAL OF MESH AND SMALL BOWEL RESECTION.

  Patient problems: Adhesion(s); Discomfort; Fluid Discharge; Hernia; Impaired Healing; Pain; Unspecified Tissue Injury

  MAUDE report 23406502 ↗
• InjuryOct 28, 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 RECURRENCE, ADHESIONS, SCARRING, DISCOMFORT AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 23406441 ↗
• InjurySep 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 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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Hematoma; Hernia; Nerve Damage; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 23099789 ↗
• 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 A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, BULGE, PAINFUL INTERCOURSE, NUMBNESS, TINGLING, PINS AND NEEDLES SENSATION, LIMITED MOBILITY, VISIBLE SCARRING, NERVE PAIN, AND OCCASIONAL BLISTERS. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH AND MEDICATION.

  Patient problems: Abdominal Distention; Adhesion(s); Blister; Discomfort; Dyspareunia; Emotional Changes; Hernia; Inflammation; Numbness; Pain; Paresthesia; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 22900976 ↗
• InjuryAug 18, 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 ADHESIONS, PAIN, INFLAMMATION, TENDONITIS, LIMITED MOBILITY, NERVE DAMAGE, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PELVIC FLOOR REPAIRS, MESH REVISION PARTIAL REMOVAL OF MESH, STEROID INJECTIONS, AND MEDICATION.

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

  MAUDE report 22828387 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLI: 10: 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, BLEEDING, EMOTIONAL INJURIES, WEAK STOMACH MUSCLES WHICH RESTRICT NORMAL ACTIVITIES, ABDOMINAL PAIN, RECURRENCE, OBSTRUCTION, HEMATOMA, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH AND MEDICATION. PLI: 20+30: 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 BLEEDING, EMOTIONAL INJURIES, WEAK STOMACH MUSCLES WHICH RESTRICT NORMAL ACTIVITIES, ABDOMINAL PAIN, RECURRENCE, OBSTRUCTION, HEMATOMA, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH AND MEDICATION.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 22462097 ↗
• InjuryMar 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 PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 21625666 ↗
• InjuryFeb 7, 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. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Distress; Pain; Sexual Dysfunction; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21334382 ↗
• InjuryOct 8, 2024Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; 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 PAIN, RECURRENCE, MESH MIGRATION, AND MESH FAILURE TO ADHERE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 20402554 ↗
• InjuryOct 1, 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, NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 20348269 ↗
• InjuryJul 31, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Distention; Adhesion(s); Emotional Changes; Erectile Dysfunction; Hernia; Impaired Healing; Inflammation; Obstruction/Occlusion; Pain; Perforation; Unspecified Tissue Injury

  MAUDE report 19875862 ↗
• InjuryJul 23, 2024Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 19812808 ↗
• InjuryJun 28, 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 RECURRENCE, ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Constipation; Hernia; Pain; Unspecified Kidney or Urinary Problem; Unspecified Tissue Injury

  MAUDE report 19638741 ↗
• InjuryJun 26, 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 RECURRENCE, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 19616598 ↗
• InjuryJun 10, 2024Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

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

  MAUDE report 19504084 ↗
• InjuryJun 6, 2024Migration 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 MESH MIGRATION, RECURRENCE, ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 19479450 ↗
• InjuryMay 13, 2024Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 19303244 ↗