Parietex TEC1410DPRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521180048), received between Jun 26, 2018 and Nov 1, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2022Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH MIGRATION, MESH SEPARATED FROM COOPER'S LIGAMENT, PAIN, ADHESIONS, MESH DEFORMATION, & CAN'T LIFT OVER 15 POUNDS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY & MEDICATION.

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

  MAUDE report 15708568 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THERE WAS RECURRENT LEFT FEMORAL HERNIA THAT HAD TO BE REPAIRED. THE BILATERAL LAPAROSCOPIC EXTRAPERITONEAL MESH HERNIA REPAIR AND HAS FAILED. THERE WAS FORMATION OF ADHESIONS IN THE INGUINAL REGION AND ONSET OF CEASELESS CHRONIC PAIN WHICH LED TO COMPLEX REGIONAL SYNDROME (CRPS).

  Patient problems: Adhesion(s); Pain

  MAUDE report 12392487 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-INGUINAL HERNIA REPAIR, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. THE PATIENT COMMUNICATED THAT RE-OPERATION WAS NEEDED FOR POSSIBLE REMOVAL OF MESH.

  Patient problems: No Code Available

  MAUDE report 8975191 ↗
• InjuryApr 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE CUSTOMER WAS CONCERNED THAT HIS ILLNESS WAS RELATED TO THE IMPLANTED MESH. IT WAS REPORTED THAT CUSTOMER WAS EXPERIENCING CHRONIC PAIN.

  Patient problems: Pain

  MAUDE report 8565437 ↗
• InjuryJun 26, 2018Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER A LAPAROSCOPIC LEFT INGUINAL HERNIA REPAIR PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED ADHESIONS, MESH DEFORMATION/MIGRATION, HERNIA RECURRENCE AND REVISION.

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

  MAUDE report 7640000 ↗