Parietex TECT1612ARRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521179967), received between Sep 19, 2017 and Feb 5, 2024 — classified as 1 death, 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2024Adverse 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 PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, BLEEDING, FISTULA, SEROMA, PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, MEDICATION, LYSIS OF ADHESIONS, OMENTECTOMY, EXPLORATORY LAPAROTOMY, PLACEMENT OF VASCULAR GRAFT, PRIMARY HERNIA REPAIR, ABDOMINOPLASTY, AND EXCISION OF INFECTED MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Discomfort; Erythema; Fistula; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Pain; Perforation; Peritonitis; Purulent Discharge; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18641829 ↗
• InjuryFeb 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 AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  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 13619377 ↗
• InjuryAug 26, 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 AN INGUINAL HERNIA AND A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION/INFECTED MESH, DENSE ADHESIONS OF BOWEL TO MESH, DRAINING SINUS, RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, HERNIA REPAIR WITH NEW MESH, REMOVAL OF MESH, AND REPAIR OF SMALL BOWEL DUE TO INJURY FROM MESH.

  Patient problems: Adhesion(s); Fluid Discharge; Hernia; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12375577 ↗
• InjuryFeb 1, 2021Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, FAILURE OF MESH, ADHESIONS, SCARRING, NERVE DAMAGE, MESHOMA, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Discomfort; Failure of Implant; Hernia; Nerve Damage; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 11259717 ↗
• InjuryDec 28, 2020Adverse 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CORD LIPOMA, RECURRENCE, CHRONIC PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hernia; Nodule; Pain; Seroma; Unspecified Tissue Injury

  MAUDE report 11078799 ↗
• InjuryMar 29, 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RIGHT GROIN NEURALGIA (PAIN), NERVE WITH SURROUNDING FIBROUS TISSUE CONSISTENT WITH NEUROMA AND SCARRING FROM PREVIOUS SURGERY. POST-OPERATIVE PATIENT TREATMENT INCLUDED ILIOINGUINAL NERVE BLOCK, NERVES DISSECTED FREE, HIGH LIGATED, AND RESECTED.

  Patient problems: Fibrosis; Injury; Nerve Damage; No Code Available; Pain; Scar Tissue; Scarring

  MAUDE report 8464700 ↗
• DeathMar 12, 2019Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, SCROTAL ABSCESS AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION AND REMOVAL SURGERY.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Bowel Perforation; Deformity/ Disfigurement; Discharge; Emotional Changes; Fatigue; Fluid Discharge; Foreign Body Reaction; Gangrene; Hematoma; Impaired Healing; Inflammation; Injury; Malaise; Muscle Weakness/Atrophy; Necrosis; No Code Available; Nodule; Pain; Peritonitis; Purulent Discharge; Scar Tissue; Scarring; Sepsis; Swelling; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Weakness

  MAUDE report 8414804 ↗
• InjuryDec 14, 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. THE PATIENT UNDERWENT LAPAROSCOPIC TOTAL EXTRAPERITONEAL RIGHT INGUINAL HERNIA REPAIR WITH MESH, LAPAROSCOPIC TOTAL EXTRAPERITONEAL LEFT INGUINAL HERNIA REPAIR WITH MESH, LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH AND LAPAROSCOPIC CLOSURE OF BLADDER LACERATION. THE PATIENT HAD REVISION SURGERY 2 MONTHS POST SURGERY. THE PATIENT EXPERIENCED CHRONIC PAIN, RECURRENCE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aspiration/Inhalation; Chest Pain; Fibrosis; Foreign Body In Patient; Hernia; Injury; No Code Available; Pain; Scar Tissue; Unspecified Tissue Injury; Vomiting

  MAUDE report 7117176 ↗
• InjurySep 19, 2017Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Integrity 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 ADHESIONS, MESH SHRINKAGE/CONTRACTURE, FAILURE OF MESH, HERNIA RECURRENCE, MENTAL PAIN, PAIN, SUFFERING, DEVICE DEFECTIVE, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND LOSS OF CARE/COMFORT/CONSORTIUM. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, PARTIAL MESH REMOVAL, AND HERNIA REPAIR WITH NEW MESHES.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Injury; No Code Available; Pain; Unspecified Tissue Injury

  MAUDE report 6877040 ↗