Parietex TECR1510Recalls & reported problems

Summary

The FDA's MAUDE database contains 199 adverse event reports that list this exact device (DI 10884521180284), received between Sep 21, 2017 and May 6, 2026 — classified as 198 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (63 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 199 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INDIVIDUAL UNDERWENT INGUINAL HERNIA SURGERY WITH IMPLANTATION OF A MESH, THE INDIVIDUAL REPORTED ABNORMAL PERSISTENT PAIN TO THE SURGEON IMMEDIATELY POST-OPERATION, AND IN THE DAYS AND WEEKS AFTER SURGERY THE PAIN GRADUALLY BECAME LASTING, DESCRIBED AS TIGHTNESS, LOCAL DISCOMFORT, AND CHRONIC PERSISTENT DAILY PAIN WITH MORE INTENSE EPISODES DEPENDING ON MOVEMENT OR ACTIVITY. THE INDIVIDUAL ALSO REPORTED NEW SYMPTOMS NOT PRESENT BEFORE THE PROCEDURE, INCLUDING PARESTHESIA IN THE HANDS AND LEGS AND FASCICULATIONS AFFECTING DIFFERENT BODY AREAS INCLUDING THE FACE AND LIMBS. ADDITIONAL DISORDERS WERE REPORTED AFTER THE SURGERY, INCLUDING A THYMIC CYST THAT WAS BEING EXPLORED, EPISODES OF LACRIMAL GLAND INFLAMMATION PREDOMINANTLY ON THE LEFT SIDE, HEARING DISORDERS, AND PHYSICAL FATIGUE. THE ONGOING SYMPTOMS WERE REPORTED TO LIMIT PERSONAL ACTIVITIES AND REDUCE ACTIVITY LEVEL, WITH PSYCHOLOGICAL IMPACT RELATED TO PERSISTENCE AND LACK OF UNDERSTANDING OF SYMPTOMS, INCLUDING A RELATIONSHIP BREAK-UP AND PSYCHOANALYTIC FOLLOW-UP. THE CONDITION WAS REPORTED AS STABILIZED WITH PERSISTENT CHRONIC PAIN.

  Patient problems: Cyst(s); Discomfort; Distress; Fatigue; Hearing Impairment; Inflammation; Pain; Paresthesia; Twitching

  MAUDE report 25096183 ↗
• InjuryJul 1, 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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Hernia; Nerve Damage; Pain; Unspecified Tissue Injury

  MAUDE report 22376347 ↗
• InjuryJun 30, 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 RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 22358966 ↗
• InjuryJan 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SCARRING, NERVE ENTRAPPED, OSTEITIS PUBIS, INFLAMMATION, PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH, MESH REVISION.

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

  MAUDE report 21231228 ↗
• InjuryJan 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SCARRING, NERVE ENTRAPPED, OSTEITIS PUBIS, INFLAMMATION, PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH, MESH REVISION.

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

  MAUDE report 21231223 ↗
• InjuryJan 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, SCARRING, EDEMA, NEUROMA, PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, EXCISION OF SCAR AND PORTION OF ILIOINGUINAL NERVE.

  Patient problems: Discomfort; Nodule; Pain; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21231124 ↗
• InjurySep 4, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, SWELLING, BRUISING, NAUSEA, FAINTNESS, NUMBNESS, TINGLING IN LEFT LEG, DISCOMFORT WITH EJACULATION, POOR SLEEP, LOW MOOD, DEPRESSION, PINS AND NEEDLES SENSATION, AND SYMPTOMS INTERFERED WITH SEXUAL ACTIVITY. POST OPERATIVE PATIENT TREATMENT INCLUDED ED VISITS, ORAL ANALGESICS, AND ORAL MEDICATION.

  Patient problems: Bruise/Contusion; Depression; Discomfort; Emotional Changes; Nausea; Numbness; Pain; Presyncope; Sexual Dysfunction; Sleep Dysfunction; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 20139265 ↗
• InjuryJul 30, 2024Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Integrity 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 MESH CONTRACTION, RECURRENCE, PAIN, EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 19864199 ↗
• InjuryJun 10, 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, INFECTION, ABSCESS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

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

  MAUDE report 19503064 ↗
• InjuryApr 29, 2024Migration 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 MESH SHRINKAGE/CONTRACTION, PAIN, RECURRENCE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

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

  MAUDE report 19209736 ↗
• InjuryMar 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, FISTULA, ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, AND REMOVAL OF MESH.

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

  MAUDE report 18980827 ↗
• InjuryFeb 14, 2024Mechanics 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 RECURRENCE, PAIN, AND MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 18705875 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  PLI10: 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: Fistula; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Perforation; Seroma; Sexual Dysfunction; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17565744 ↗
• InjuryJul 17, 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 THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, INFECTION, ABSCESS, AND CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, DEBRIDEMENT, EVACUATION OF PRE-PERITONEAL ABSCESS, DRAIN PLACEMENT, MEDICATION, AND MESH REMOVAL.

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

  MAUDE report 17339326 ↗
• InjuryJun 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABSCESS AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abscess; Pain; Unspecified Tissue Injury

  MAUDE report 17131957 ↗
• InjuryMay 31, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH.

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

  MAUDE report 17035287 ↗
• InjuryMay 31, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH.

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

  MAUDE report 17035277 ↗
• InjuryApr 27, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16824648 ↗
• 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 IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH MESH.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 16660493 ↗
• InjuryMar 18, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENT PAIN IN LOWER ABDOMEN, HERNIA RECURRENCE, ADHESIONS, MESH FAILURE BY EVENTRATION/INVAGINATION INTO DEFECT, INCARCERATION OF HERNIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED USE OF DRAIN.

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

  MAUDE report 16569454 ↗
• InjuryJan 31, 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 FAILURE OF MESH, DEFECTIVE MESH, MESH MIGRATION, PAIN, EMOTIONAL DISTRESS, DISABILITY, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE, IMPAIRMENT, INFLAMMATION, RECURRENCE, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED LEFT INGUINAL REPAIR.

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

  MAUDE report 16275120 ↗
• InjuryDec 28, 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 RECURRENCE, ADHESIONS, CHRONIC PAIN, MESH FAILURE, DISCOMFORT, SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY SURGERY WITH SEROMA REPAIR, ADHESIOLYSIS. REVISION SURGERY, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 16064328 ↗
• InjuryNov 28, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, MENTAL PAIN, PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Ambulation or Postural Difficulties; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Depression; Discomfort; Emotional Changes; Fatigue; Fibrosis; Hernia; Muscle Weakness/Atrophy; Numbness; Pain; Paresthesia; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15872474 ↗
• InjuryNov 2, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, CHRONIC PAIN, & SPERMATIC CORD INVOLVEMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 15718545 ↗
• InjuryOct 13, 2022Adverse 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, OBSTRUCTION, PERFORATION, SEROSAL TEAR, AND INCARCERATION OF HERNIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, USE OF A DRAIN, AND BOWEL RESECTION.

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

  MAUDE report 15600955 ↗