Parietex TCM4530Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521178939), received between Jan 17, 2018 and Dec 29, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, DISRUPTION MESH, CHRONIC PAIN, BULGE, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH AND MESH RE-SECURED.

  Patient problems: Abdominal Distention; Discomfort; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 11090218 ↗
• InjuryNov 5, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SMALL BOWEL OBSTRUCTION, PAIN, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, INFLAMMATION, ADHESIONS AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH INTERVENTION SURGERY.

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

  MAUDE report 9277973 ↗
• InjuryJan 17, 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT THE PLACEMENT OF A MESH. SHE HAD REVISION SURGERY 2 YEARS AND 5 MONTHS POST-SURGERY. THE PATIENT EXPERIENCED PAIN, ADHESIONS, RECURRENCE, AND SURGERY. MEDICAL HISTORY: HYPERTENSION, DEPRESSION, GERD, FIBROIDS, AND MORBID OBESITY (BMI 40.0 - 49.9).

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

  MAUDE report 7199538 ↗