Strattice Reconstructive Tissue Matrix 1020002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M32810200020), received between Oct 3, 2022 and Oct 17, 2022 — classified as 2 injuries.

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.

• InjuryOct 17, 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 69 YEAR OLD MAN UNDERWENT A HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2014. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH IN HIM. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2015 FOR A REVISION SURGERY. SUBSEQUENTLY, THE PATIENT RETURNED TO THE HOSPITAL AGAIN ON OR ABOUT (B)(6) 2016 FOR A MESH EXPLANT SURGERY. ON SEPTEMBER 19, 2022, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE LOTS ASSOCIATED WITH THIS EVENT WERE FOUND THROUGH DISCOVERY AND ARE (B)(4) ((B)(6) 2014 IMPLANT) AND (B)(4) ((B)(6) 2015 IMPLANT). NO OTHER INFORMATION WAS PROVIDED. THE ORIGINAL SUMMONS DID NOT REPORT THAT A STRATTICE DEVICE WAS IMPLANTED DURING THE (B)(6) 2015 AND THEREFORE THIS RECORD WAS ORIGINALLY CANCELLED. SINCE UPDATED INFORMATION WAS RECEIVED THAT A SECOND STRATTICE DEVICE WAS IMPLANTED, THIS RECORD WAS RE-OPENED DUE TO THE REPORT OF DEVICE EXPLANT OCCURRING AFTER THE SECOND DEVICE WAS IMPLANTED AND AN INVESTIGATION WILL BE PERFORMED ON (B)(4). THE EVENT CODE WAS UPDATED TO 'REHERNIATION" IN THE ASSUMPTION THE REVISION SURGERY WAS TO REPAIR A RECURRENCE.

  Patient problems: Hernia

  MAUDE report 15615941 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE FOLLOW UP OF (B)(4), ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT WAS ALSO IMPLANTED WITH A SECOND STRATTICE DEVICE ON (B)(6) 2021. TRANSPLANT BRING BACK LIVER-- ADDITIONAL PIECE OF STRATTICE MESH WAS USED IN COMBINATION WITH WHAT HAD BEEN PLACED THE DAY PRIOR." GRFT STR 10X20 - SN/A - (B)(4), 1, ALLERGAN MEDICAL 1020002, N/A " IT WAS REPORTED THE PATIENT UNDERWENT A TRANSPLANT BRING BACK LIVER ON (B)(6) 2021, AND THE PREVIOUSLY PLACED BIOLOGIC STRATTICE MESH WAS EXCISED AND WAS SENT FOR CULTURE AND PATHOLOGY. IT IS NOT CLEAR FROM THE ADDITIONAL INFORMATION WHICH DEVICE WAS EXPLANTED AND SENT FOR PATHOLOGY. ALTHOUGH RECORD (B)(4) PROVIDED A LOT NUMBER, IT DOES NOT CLEARLY INDICATE IT WAS THE DEVICE THAT WAS EXPLANTED. THEREFORE THIS RECORD WAS OPENED FOR THE SECOND DEVICE OUT OF AN ABUNDANCE OF CAUTION DUE TO THE REPORT OF INFECTION WITH DEVICE EXPLANT. NO LOT NUMBER WAS PROVIDED FOR THE SECOND DEVICE, HOWEVER IT APPEARS IT COULD BE A STRATTICE 10X20 BASED ON THE INFORMATION PROVIDED "GRFT STR 10X20." THE ORIGINAL INFORMATION STATED THAT A "61 YEAR OLD MALE PATIENT WHO WEIGHED 71 KGS UNDERWENT SIMULTANEOUS LIVER-KIDNEY TRANSPLANT. MULTIPLE RETURNS TO OR FOR COMP

  Patient problems: Fungal Infection

  MAUDE report 15532273 ↗