Parietex TECT1510ADP2LRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521180154), received between Jan 18, 2018 and Nov 14, 2024 — classified as 11 injuries, 1 malfunction.

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 16, 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.

• InjuryNov 14, 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ITCHY GROIN RASH, MERALGIA PARAESTHETICA, ABDOMINAL PAIN, PAIN, DISCOMFORT, SWELLING, HERNIA RECURRENCE, & WEIGHT GAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED PAIN MEDICATION.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hernia; Itching Sensation; Pain; Rash; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 20686978 ↗
• MalfunctionSep 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) HERNIOPLASTY, WHILE THE UROLOGIST PREPARING TO USE THE MESH, IT WAS FOUND THE MESH'S LINE WAS SNAP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287583 ↗
• InjuryNov 15, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED WOUND INFECTION, ABSCESS, ABDOMINAL WOUND, ABDOMINAL WALL INFECTION, RECURRENCE, ADHESIONS, & CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, WOUND INFECTION TREATMENT, ABSCESS/ABDOMINAL WOUND/ABDOMINAL WALL INFECTION DRAINAGE, & HERNIA REPAIR.

  Patient problems: Abscess; Adhesion(s); Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Pain; Perforation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15799702 ↗
• InjuryApr 30, 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 A LEFT INGUINAL HERNIA AND AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DENERVATION OF SPERMATIC CORD, RECURRENCE, AND NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED NERVE AND CORD BLOCKS, LEFT RADICAL ORCHIECTOMY, AND BOTOX ABLATION.

  Patient problems: Hernia; Nerve Damage; Unspecified Tissue Injury

  MAUDE report 11757841 ↗
• InjuryDec 21, 2020Mechanics 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ALL ASPECTS OF LIFE NEGATIVELY IMPACTED, MESH FAILURE, EMOTIONAL HARM, DISCOMFORT, RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, HERNIA REPAIR WITH NEW MESH, REVISION SURGERY AND REMOVAL OF MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Erythema; Fatigue; Foreign Body Reaction; Hernia; Nausea; Numbness; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11050391 ↗
• InjurySep 29, 2020Mechanics 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 LEFT INGUINAL HERNIA. A AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMO VAL.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Emotional Changes; Hernia; Injury; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 10603761 ↗
• InjuryJul 6, 2020Migration 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 10232586 ↗
• InjuryApr 22, 2020Adverse 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED FISTULA, INFECTION, MESH EROSION INTO COLON, ABSCESS, PURULENT MATERIAL, INADVERTENT BLADDER DEFECT, FIBROTIC TISSUE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LAPAROSCOPIC SIGMOID COLECTOMY WITH SPLENIC FLEXURE MOBILIZATION, TAKEDOWN OF COLOCUTANEOUS AND COLOVESICAL FISTULA WITH PRIMARY COLORECTAL ANASTOMOSIS, TAKEDOWN OF SMALL BOWEL TO BLADDER FISTULA (ILEOVESICAL) FISTULA, LYSIS OF ADHESIONS, HERNIA REPAIR, DRAINAGE OF ABSCESS, REMOVAL OF MESH, BLADDER REPAIR WITH PLACEMENT OF SUPRAPUBIC CATHETER, AND SMALL BOWEL RESECTION WITH PRIMARY ILEAL-ILEAL ANASTOMOSIS.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Fibrosis; Fistula; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Injury; No Code Available; Obstruction/Occlusion; Pain; Perforation; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9986595 ↗
• InjuryMar 2, 2020Migration 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFECTION, ADHESIONS, AND MESH SHIFTED. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Distress; Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Injury; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9773620 ↗
• InjuryOct 7, 2019Migration 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 A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, OBSTRUCTION, ABDOMINAL PAIN, HERNIA RECURRENCE, MESH MIGRATION, MESH FAILURE, MESH ADHERED TO VAS DEFERENS AND SPERMATIC CORD. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MEDICATION.

  Patient problems: Abdominal Pain; Adhesion(s); Failure of Implant; Hernia; Injury; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 9164886 ↗
• InjuryAug 20, 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, AND A SYMPTOMATIC RIGHT SPERMATOCELE (SPERMATIC CYST). TREATMENT INCLUDED A SPERMATOCELECTOMY AND SURGICAL REVISION OF THE MESH.

  Patient problems: Adhesion(s); Injury

  MAUDE report 7799814 ↗
• InjuryJan 18, 2018Adverse 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PROCEDURE PERFORMED WAS LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR WITH MESH. THE PATIENT HAS HAD PAIN, RECURRENCE, AND SURGERY.

  Patient problems: Abscess; Adhesion(s); Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Discharge; Fistula; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Injury; No Code Available; Pain; Seroma; Skin Erosion; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 7203886 ↗