Strattice Reconstructive Tissue Matrix Laparoscopic 1620005Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M32816200050), received between May 6, 2022 and Sep 19, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2014. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 17773970 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH 1ST STRATTICE ON (B)(6) 2017 AND A 2ND STRATTICE ON (B)(6) 2017. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 1000306051-2023-00193 (ABBVIE COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND STRATTICE.

  Patient problems: Hernia

  MAUDE report 17661591 ↗
• InjuryJun 10, 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 48 YEAR OLD FEMALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2019. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; CATALOG 1520005, LOT NO. SP100632-139. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2019 AND WAS DIAGNOSED WITH AN EXTREME FIBROTIC REACTION TO STRATTICE AND ABDOMINAL WALL INFECTION AND UNDERWENT A MESH REMOVAL OPERATION.

  Patient problems: Bacterial Infection; Foreign Body Reaction

  MAUDE report 14653660 ↗
• InjuryMay 6, 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) MALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2015. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH LOT SP100151-096. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2016 AND WAS DIAGNOSED WITH A RECURRENT HERNIA. ON OR ABOUT (B)(6) 2016 THE PATIENT UNDERWENT A MESH REVISION OPERATION. AS PART OF THE REVISION SURGERY, THE SURGEON IMPLANTED ANOTHER STRATTICE MESH, LOT NO. SP100288-057. FOLLOWING THE REVISION SURGERY, THE PATIENT AGAIN RETURNED TO THE HOSPITAL ON (B)(6), 2016, WHERE THE PATIENT WAS DIAGNOSES WITH A RECURRENT INCARCERATED VENTRAL HERNIA. ON (B)(6) 2016, THE SURGEON IMPLANTED A THIRD STRATTICE MESH, LOT NO. SP100503-132. THIS RECORD IS ASSOCIATED WITH THE SECOND DEVICE IMPLANTED ON (B)(6), 2016, LOT SP100288-057. AS PER THE REPORTED INFORMATION, THERE IS NO COMPLAINT AGAINST THE THIRD DEVICE LOT SP100503-132.

  Patient problems: Hernia

  MAUDE report 14305436 ↗