Strattice Reconstructive Tissue Matrix Perforated 1535002PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M3281535002P0), received between Jan 30, 2023 and Jan 30, 2023 — 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 45 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2021. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; LOT # SP200233-093 REF # 1535002P MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2022 FOR A REVISION SURGERY AND ADDITIONAL STRATTICE MESH WAS IMPLANTED. PLAINTIFF CONTINUES TO EXPERIENCE COMPLICATIONS. IT WAS REPORTED A SECOND DEVICE WAS IMPLANTED ON (B)(6) 2022 AND THE PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS; HOWEVER SINCE THERE IS NO DATE OF OCCURRENCE OR ADDITIONAL DETAILS PROVIDED AGAINST THE SECOND DEVICE, A SECOND RECORD WILL NOT BE OPENED.

  Patient problems: Hernia

  MAUDE report 16264893 ↗