Parietex TEC2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521180277), received between Apr 4, 2018 and Sep 5, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA, SEROMA, ADHESIONS, BACTERIAL INFECTION, FLUID COLLECTION, INFLAMMATION, ABDOMINAL PAIN, NAUSEA, RETCHING, TENDERNESS, OBSTRUCTION, FEVER, ABSCESS, PUS, INFECTION, BULGE, DISCOMFORT, AND VOMITING. POST OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, IV FLUIDS, PAIN MEDICATION, HOSPITAL ADMISSION, HERNIA REPAIR WITH NEW MESH, SAC EXCISED, MESH REVISED, ANTIBIOTICS, INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS, PUS DRAINED, WASHOUT OF ABDOMINAL WOUND, AND WOUND VAC.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Discomfort; Fever; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 20150151 ↗
• InjurySep 5, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA, SEROMA, ADHESIONS, BACTERIAL INFECTION, FLUID COLLECTION, INFLAMMATION, ABDOMINAL PAIN, NAUSEA, RETCHING, TENDERNESS, OBSTRUCTION, FEVER, ABSCESS, PUS, INFECTION, BULGE, DISCOMFORT, AND VOMITING. POST OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, IV FLUIDS, PAIN MEDICATION, HOSPITAL ADMISSION, HERNIA REPAIR WITH NEW MESH, SAC EXCISED, MESH REVISED, ANTIBIOTICS, INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS, PUS DRAINED, WASHOUT OF ABDOMINAL WOUND, AND WOUND VAC.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Discomfort; Fever; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 20150136 ↗
• InjuryDec 27, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY.

  Patient problems: Abdominal Distention; Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Obstruction/Occlusion; Pain; Unspecified Tissue Injury; Urinary Frequency / Polyuria

  MAUDE report 13087550 ↗
• InjuryAug 16, 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, INFECTION, ADHESIONS, AND SINUS TRACT. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, REMOVAL OF MESH, MESH DISSECTED AWAY, WOUND VAC, WASHOUT OF WOUND, AND ABDOMINAL WALL EXCISION.

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

  MAUDE report 12324545 ↗
• InjuryJul 23, 2021Adverse 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANTS, THE PATIENT EXPERIENCED INFECTION/INFECTED MESH, DRAINING FISTULA, CHRONIC DRAINING ABDOMINAL WALL SINUSES, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ABDOMINAL WASHOUT, SKIN CLOSURE, LAPAROTOMY, AND REMOVAL OF MESH.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Pain; Perforation; Seroma; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12217613 ↗
• InjuryJul 15, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, PAIN, AND NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL MESH REMOVAL, AND EXCISION OF ILIOHYPOGASTRIC NERVE.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma; Hernia; Hyperesthesia; Hyperresponsive to stimuli; Inflammation; Nausea; Nerve Damage; Numbness; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 12174359 ↗
• InjurySep 11, 2019Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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 CHRONIC WOUND, SINUS AND WOUND INFECTION, INFECTED ABDOMEN AND WOUND WITH WOUND SINUS, CHRONIC DRAINING SINUS, CHRONIC NON-HEALING WOUND, INFECTED MESH, UNINCORPORATED MESH, AND FISTULA TRACT. POST-OPERATIVE PATIENT TREATMENT INCLUDED INCISION AND DRAINAGE OF CHRONIC WOUND, APPLICATION OF WOUND VAC, REMOVAL OF SEVERAL PIECES OF MESH MATERIAL, DEBRIDEMENT WITH REMOVAL OF MESH, AND EXCISION OF RETAINED MESH WITH NONHEALING WOUND EXPLORATION AND DEBRIDEMENT. THE DEVICE HAD BEEN USED WITH CONCOMITANT DEVICES WL GORE MYCROMESH PLUS 15X19 (X2), LOT#'S 13374847 AND 15148973.

  Patient problems: Discharge; Fistula; Impaired Healing; Injury; Unspecified Infection

  MAUDE report 8987441 ↗
• InjuryApr 4, 2018Migration 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT A BILATERAL INGUINAL HERNIA REPAIR WITH MESH. HE HAD REVISION SURGERY 2 YEARS AND 3 MONTHS POST-SURGERY. THE PATIENT EXPERIENCED PAIN, ADHESIONS, REHERNIATION, SCARRING.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis; Foreign Body Reaction; Hernia; Inflammation; Injury; Nerve Damage; Obstruction/Occlusion; Pain; Scar Tissue; Scarring; Sexual Dysfunction; Unspecified Tissue Injury

  MAUDE report 7396057 ↗