Parietex TCM1515X3Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521178885), received between Oct 5, 2017 and Jun 27, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 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 REVISION SURGERY.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22350654 ↗
• InjuryMar 3, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

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

  MAUDE report 16479704 ↗
• InjuryJul 2, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN SYNDROME, HEMATOMA, AND OPEN DRAINING WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC, AND REVISION SURGERY.

  Patient problems: Adhesion(s); Discomfort; Distress; Emotional Changes; Fibrosis; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12112383 ↗
• InjuryMay 14, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, DISCOMFORT, MENTAL PAIN, MENTAL ANGUISH, EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, INFLAMMATION, AND SEVERE PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REVISION SURGERY.

  Patient problems: Discomfort; Distress; Emotional Changes; Hernia; Inflammation; Muscle Weakness/Atrophy; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11828689 ↗
• InjuryMay 7, 2021Migration 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, DIASTASIS, PAIN, AND MESH WAS LOOSE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, THINNED OUT FASCIA EXCISED, ADHESIOLYSIS, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 11791580 ↗
• InjuryMar 11, 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 AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, AND MODIFICATION.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 11462274 ↗
• InjuryJan 7, 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 THE IMPLANT, THE PATIENT EXPERIENCED SCAR TISSUE, RECURRENCE, FIBROUS TISSUE, FOREIGN BODY GRANULOMAS REACTION, AND PAIN/SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Emotional Changes; Fibrosis; Foreign Body Reaction; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11132757 ↗
• InjuryMay 11, 2020Adverse 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA AND BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED OBSTRUCTION AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Injury; Nausea; Obstruction/Occlusion; Pain; Unspecified Tissue Injury; Vomiting

  MAUDE report 10045032 ↗
• InjuryJul 2, 2019Migration 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, DENSE INTERNAL SCARRING AND MESH CONTRACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED NERVE TRANSECTION AND EXCISION.

  Patient problems: Adhesion(s); Emotional Changes; Fibrosis; Hernia; Injury; Pain; Scar Tissue; Scarring; Unspecified Tissue Injury

  MAUDE report 8756276 ↗
• InjuryJan 15, 2019Adverse 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND DENSE ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL REVISIONS AND RECURRENCE REPAIR.

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

  MAUDE report 8250777 ↗
• InjurySep 10, 2018Mechanics 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, HERNIA RECURRENCE, CONSTIPATION, BURNING WITH VOIDING, TENDERNESS, SWELLING, WEIGHT GAIN, CORD LIPOMA, INFLAMED ILIOINGUINAL NERVE DIVIDED, BULKY LYMPH NODES, DENSE SCAR BED, AND DENSE ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, RIGHT GROIN EXPLORATION, AND EXCISION OF ASSOCIATED CORD LIPOMA.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Constipation; Discomfort; Emotional Changes; Hernia; Inflammation; Injury; Nerve Damage; No Code Available; Pain; Scar Tissue; Scarring; Swelling; Swelling/ Edema; Unspecified Tissue Injury; Weight Changes

  MAUDE report 7862125 ↗
• InjuryOct 5, 2017Adverse 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PREOPERATIVE ­­­­­­­­­­­­­­­­­­­AND POSTOPERATIVE DIAGNOSIS WAS LEFT INGUINAL HERNIA AND LEFT INGUINAL SKIN TAG. THE PROCEDURE PERFORMED WAS LAPAROSCOPIC REPAIR OF INCARCERATED VENTRAL HERNIA WITH 15-CM ROUND MESH PLACED IN THE PREPERITONEAL LOCATION. THE PATIENT UNDERWENT A SECOND SURGICAL PROCEDURE OF A LAPAROSCOPIC DAVINCI-ASSISTED REPAIR OF VERY LARGE LEFT INGUINAL HERNIA, INCARCERATED AND EXCISION OF LEFT INGUINAL SKIN TAG. PRE-OPERATIVE AND POST-OPERATIVE DIAGNOSIS WAS LEFT INGUINAL HERNIA AND LEFT INGUINAL SKIN TAG. THE PATIENT ALSO HAS HAD A SURGICAL REVISION AND RECURRENCE.

  Patient problems: Injury; No Code Available

  MAUDE report 6916849 ↗