Parietex TECR1410DP2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521180062), received between Nov 30, 2018 and Oct 20, 2020 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionOct 20, 2020Loss of or Failure to Bond; Product Quality Problem; Loss of or Failure to Bond; Product Quality Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL INGUINAL HERNIA REPAIR, AFTER THE INSERTION TO THE PATIENT DURING MESH DEPLOYMENT AND PLACEMENT, THERE APPEARED TO BE A KNOT IN THE THREAD. WHEN THE SURGEON WENT TO PULL THE THREAD OUT OF THE MESH TO POSITION IT INSIDE THE PATIENT, THE THREAD KEPT GATHERING AND PULLING THE MESH. THERE WAS A KNOT WHICH THE SURGEON HAD TO CUT TO REMOVE THE THREAD AND DEPLOY THE MESH. THE THREAD THEN CAME OUT IN 2 SEPARATE PIECES. EXTRA TIME OF ABOUT 15 MINUTES WAS ADDED TO THE PROCEDURE DUE TO THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10707865 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER FOLLOWING A RIGHT DIRECT INGUINAL PROCEDURE THE PATIENT FELT LIKE THERE WAS RAZOR BLADES IN HIS GROIN AND THAT THE PATIENT FELT LIKE A FLAMMABLE LIQUID LIT ON FIRE. THE PATIENT CURRENTLY SPENDS THE TIME BEDRIDDEN AND NEEDS A CANE TO GET AROUND.

  Patient problems: Disability; Pain

  MAUDE report 8223972 ↗
• MalfunctionNov 30, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, WHEN THEY WERE ABOUT TO PLACE THE MESH IN THE INGUINAL SPACE ON A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL PROCEDURE, THEY NOTICED THAT A 1-2 CM DEFECT WAS PRESENT ON THE MESH. THE SURGEON USED AN ALTERNATE MESH TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8119290 ↗