Parietex TEC1410P5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521180055), received between Oct 22, 2019 and Jun 25, 2024 — classified as 2 malfunctions.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2024Packaging Problem; Material Split, Cut or Torn; Packaging Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, BEFORE IT WAS DELIVERED TO THE HOSPITAL. THERE WAS A TEAR ON THE DEVICE DUE TO A DAMAGED PACKAGING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608364 ↗
• MalfunctionOct 22, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING DEPLOYMENT OF MESH ON A TRANSABDOMINAL PREPERITONEAL REPAIR, THE SURGEON PULLED THE THREAD WITH USUAL POWER BUT IT BROKE EASILY AND COULD NOT DEPLOY THE MESH. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9218871 ↗