Strattice Reconstructive Tissue Matrix 1525002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M32815250020), received between Mar 21, 2022 and Mar 21, 2022 — 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.

• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL EVENT THAT A (B)(6) YEAR OLD MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2018. DURING THE PATIENT'S HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2020. THE PATIENT REPORTED INTERMITTENT PAIN, DIFFICULTY BREATHING WHEN HERNIA WAS PROTRUDING, AND A DECREASE IN HIS ABILITY TO PERFORM HIS DAILY ACTIVITIES. HE WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA. ON OR ABOUT (B)(6) 2020, THE PATIENT UNDERWENT A COMPLEX RECURRENT INCISIONAL HERNIA REPAIR, LYSIS OF ADHESIONS OF OMENTUM AND SMALL BOWEL TO STRATTICE MESH, EXCISION OF ABDOMINAL WALL FOREIGN BODY, COMPONENT SEPARATION, AND PLACEMENT OF ADDITIONAL MESH.

  Patient problems: Hernia

  MAUDE report 13844226 ↗