Parietex TECR3030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521180314), received between Sep 6, 2024 and Sep 6, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2024Migration 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED BACTERIAL INFECTION, MUSCULATURE AND ABDOMINAL WALL SEVERELY ATROPHIC, RESIDUAL BULGING, SEEPAGE FROM WOUND, HEMATOMA, PAIN, ADHESIONS, ABDOMINAL PAIN, DISTENTION, MESH MASS, SEROUS DRAINAGE FROM WOUND, PUS, WOUND INFECTION, CRAMPING, EXCESSIVE FLATULENCE, DISCOMFORT, ABDOMINAL WALL WEAKNESS, TENDERNESS, ABDOMINAL SCAR, SPASMS, BLOATING, NOT SLEEPING, ANXIETY, ENTEROTOMY, FISTULA, AND MISERABLE QUALITY OF LIFE. POST OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, INCISION AND DRAINAGE OF WOUND/HEMATOMA, DRAIN PLACEMENT, OSTOMY BAG PLACEMENT, LAP DIVISION OF ADHESIONS, LAPAROSCOPY, MOBILIZATION OF COLON AND ILEUM, RIGID SIGMOIDOSCOPY, MESH PARTIALLY DIVIDED, LAPAROTOMY, HERNIA REPAIR WITH MESH, ANTIBIOTICS, MESH REVISION, HOSPITAL ADMISSION, GANGLION NERVE BLOCKS, DIAGNOSTIC LAPAROSCOPY, AND REPAIR OF ENTEROTOMY.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Cramp(s) /Muscle Spasm(s); Discomfort; Emotional Changes; Fistula; Flatus; Fluid Discharge; Hematoma; Impaired Healing; Muscle Weakness/Atrophy; Nodule; Pain; Purulent Discharge; Scar Tissue; Sleep Dysfunction; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20161648 ↗