Parietex TECT1510ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 255 adverse event reports that list this exact device (DI 10884521180321), received between Sep 22, 2017 and Aug 20, 2026 — classified as 1 death, 254 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (78 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 255 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 an inguinal hernia. It was reported that after implant, the patient experienced nerve damage, pain, suffering, 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 50356563 ↗
• InjuryJun 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, NERVE DAMAGE, PAIN, SUFFERING, INFECTION, HYDROCELE, SCARRING, INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LEFT ORCHIECTOMY WITH TESTICULAR PROSTHESIS, ILIOINGUINAL INJECTIONS.

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

  MAUDE report 25512815 ↗
• InjuryMar 26, 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, BOWEL OBSTRUCTION, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION AND REVISION SURGERY.

  Patient problems: Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 24705787 ↗
• InjuryMar 10, 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 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 24559997 ↗
• 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 24551293 ↗
• 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ENTEROLYSIS, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 23706225 ↗
• 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 23406439 ↗
• 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 AN INGUINAL AND UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, NERVE DAMAGE, PAIN, SUFFERING AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 23303152 ↗
• InjuryOct 1, 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; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23196665 ↗
• 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 22900978 ↗
• 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, MEDICATION.

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

  MAUDE report 22828414 ↗
• InjuryAug 4, 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A UMBILICAL & INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, OBSTRUCTION, ADHESION, EMOTIONAL DISTRESS, AND INCARCERATE LOOPS OF BOWEL AND OMENTUM. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, & PARTIAL REMOVAL OF MESH.

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

  MAUDE report 22701504 ↗
• 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 22462089 ↗
• InjuryJun 12, 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, EXTREME BRUISING, PUFFINESS, NUMBNESS AND LIMITED MOTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Bruise/Contusion; Hernia; Numbness; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 22196834 ↗
• InjuryJun 3, 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, EMOTIONAL CHANGES, DISCOMFORT, MESH FAILURE, PAIN, LARGE HYDROCELE, BULGE, OBSTRUCTION, CORD LIPOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, HERNIA REPAIR WITH NEW MESH, HYDROCELE SAC EXCISED.

  Patient problems: Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Hernia; Nodule; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 22138196 ↗
• InjuryJun 2, 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 PAIN, RECURRENCE, ADHESIONS, MESH FAILURE, EMOTIONAL HARM, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, ADHESIOLYSIS AND MEDICATION.

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

  MAUDE report 22126379 ↗
• 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 21625658 ↗
• InjuryDec 9, 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 20883581 ↗
• 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 20349014 ↗
• 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 19812740 ↗
• 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 19479478 ↗
• InjuryFeb 14, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Dysuria; Hernia; Inflammation; Pain; Scar Tissue; Tinnitus; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18705789 ↗
• InjuryDec 28, 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 PAIN IN THE GENITAL AREA TO THE RIB CAGE, HEMATOMA, RECURRENCE AND MESH BALLED UP. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Distention; Adhesion(s); Hematoma; Hernia; Nodule; Pain; Unspecified Tissue Injury

  MAUDE report 18416146 ↗
• InjuryDec 7, 2023Adverse 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, <(>&<)> CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 18288387 ↗
• InjuryOct 19, 2023Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; Material Integrity Problem; 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 RECURRENCE, INFECTION, PAIN, MESH EXPULSION, AND CONTRACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 17970920 ↗