Parietex TECT1612AFRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521179950), received between Sep 21, 2017 and Apr 30, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, SEROMA, NERVE DAMAGE, MESH MIGRATION, CYST, IN GUINODYNIA, SCARRING, AND HEMATOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, TRIPLE NEURECTOMY OF ILIOINGUINAL NERVES, REMOVAL OF CYST LIKE STRUCTURE, REMOVAL OF SUTURES, AND REMOVAL OF HEMATOMA/SEROMA.

  Patient problems: Cyst(s); Hematoma; Nerve Damage; Pain; Scar Tissue; Seroma; Unspecified Tissue Injury

  MAUDE report 11753412 ↗
• InjuryFeb 19, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, INFECTED MESH, ABSCESS, SEROMA, DENSE INFLAMMATORY REACTION WITH SCAR FORMATION, ADHESIONS, BLADDER INJURY, RECURRENCE, INSOMNIA, PAIN, TRAUMATIC URETHRAL STRICTURE, AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, FLEXIBLE CYSTOURETHROSCOPY, REPLACEMENT OF SUPRAPUBIC TUBE, AND REPAIR OF HERNIA WITH MESH.

  Patient problems: Abdominal Cramps; Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Discomfort; Distress; Emotional Changes; Fatigue; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Muscle Weakness/Atrophy; Nausea; Necrosis; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Sleep Dysfunction; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 11348915 ↗
• InjuryAug 14, 2019Mechanics 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 MESH INFECTION, CHRONIC INFLAMMATION, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, AND MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Cramp(s) /Muscle Spasm(s); Diaphoresis; Diarrhea; Discomfort; Electrolyte Imbalance; Emotional Changes; Failure of Implant; Fibrosis; Fluid Discharge; Inflammation; Injury; Nausea; Nodule; Obstruction/Occlusion; Pain; Pleural Effusion; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 8893493 ↗
• InjuryMay 8, 2018Adverse 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. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED RE-HERNIATION. AFTER THE ORIGINAL PROCEDURE, ADDITIONAL POTENTIALLY RELATED PROCEDURES WERE PERFORMED.

  Patient problems: Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Injury; Muscle Weakness/Atrophy; No Code Available; Nodule; Pain; Unspecified Tissue Injury

  MAUDE report 7496255 ↗
• InjuryDec 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. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF A RECURRENT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTIONS, BULGE, FIBROCOLLAGENOUS TISSUE, INFLAMMATION, PAIN, OBLITERATED PERITONEAL SPACE, SCARRING, CORD LIPOMA, APONEUROSIS, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Fibrosis; Hernia; Inflammation; Injury; Nerve Damage; No Code Available; Pain; Scar Tissue; Scarring; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 7083638 ↗
• InjurySep 21, 2017Loss of or Failure to Bond; Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER PREPERITONEAL IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SEROMA, BULGING, PAIN, HERNIA RECURRENCE, MESH NOT COMPLETELY INCORPORATED AND HAD RETRACTED AND SHRUNK. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL. THE DEVICE HAD BEEN USED WITH PHYSIOMESH 20 X 25 CM ON (B)(6) 2011.

  Patient problems: Abdominal Distention; Adhesion(s); Hernia; Injury; Pain; Seroma

  MAUDE report 6884235 ↗