Strattice Reconstructive Tissue Matrix Perforated 2020002PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M3282020002P0), received between Jul 13, 2021 and Jul 13, 2021 — classified as 1 injury.

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.

• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE UNDERWENT A VENTRAL/UMBILICAL HERNIA REPAIR ON (B)(6) 2013 AND WAS IMPLANTED WITH STRATTICE LOT S11301-041. TWO YEARS AFTER THE SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2015 AND WAS DIAGNOSED WITH A PARTIAL SMALL BOWEL OBSTRUCTION. THE PATIENT HAD A RELEASE OF PARTIAL SMALL BOWEL OBSTRUCTION, REPAIR OF RECURRENT VENTRAL/UMBILICAL HERNIA AND REMOVAL OF OLD MESH AT MEDICAL WEST HOSPITAL PERFORMED BY DR. ISSIS. THE PATIENT WAS IMPLANTED WITH ANOTHER PIECE OF STRATTICE, LOT SP100295-142. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON JANUARY 7TH, 2016 AND WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION. ON (B)(6) 2016, THE PATIENT HAD A RELEASE OF SMALL BOWEL OBSTRUCTION, RELEASE OF INTERNAL HERNIA AND EXCISION OF STRATTICE MESH A MEDICAL WEST HOSPITAL. THIS RECORD IS ASSOCIATED WITH THE SECOND REPORTED LOT, SP100295-142.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12161083 ↗