Strattice Reconstructive Tissue Matrix 1010002Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI M32810100020), received between Apr 16, 2018 and May 10, 2024 — classified as 18 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2024Adverse 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 19287308 ↗
• InjuryMay 4, 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 54 YEAR OLD PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2017. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; LOT NO.: SP100350; LIFECELL STRATTICE. FOLLOWING THE INITIAL IMPLANT OF MESH DEVICE, AND DUE TO COMPLICATIONS CONCERNING SAME, THE PATIENT WAS REQUIRED TO UNDERGO PROCEDURES FOR AN ABDOMINAL WOUND, DRAINAGE, AND INFECTION ON OR ABOUT (B)(6) 2017, AND (B)(6) 2017; AND REVISION SURGERIES, INCLUDING ADDITIONAL MESH IMPLANTATION AS FOLLOWS: ON OR ABOUT (B)(6) 2017, WHEN PATIENT WAS IMPLANTED WITH LIFECELL STRATTICE MESH, LOT NO. SP100472-133; AND (B)(6) 2019, WHEN PATIENT WAS IMPLANTED WITH LIFECELL STRATTICE MESH, LOT NO.: SP200063-023. NO OTHER INFORMATION WAS REPORTED. THIS RECORD IS ASSOCIATED WITH DEVICE LOT SP100472-133, IMPLANTED (B)(6) 2017. IT WAS ALSO REPORTED THE PATIENT WAS IMPLANTED WITH DEVICE LOT NO.: SP200063-023 ON (B)(6) 2019 HOWEVER THERE IS NO EVENT REPORTED AFTER THE IMPLANTATION AND THEREFORE AN ADDITIONAL COMPLAINT RECORD WILL NOT BE OPENED FOR SP200063-023. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR # 1000306051-2023-00098 (ABBVIE COMPLAINT # PR # (B)(4).

  Patient problems: Hernia

  MAUDE report 16871495 ↗
• InjuryMay 4, 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 59 MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2018. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; LOT NO. SP100559. FOLLOWING THE INITIAL IMPLANT OF THE MESH DEVICE, AND DUE TO COMPLICATIONS CONCERNING SAME, THE PATIENT WAS REQUIRED TO UNDERGO REVISION SURGERIES, INCLUDING ADDITIONAL MESH IMPLANTATION AS FOLLOWS: ON OR ABOUT (B)(6) 2018, WHEN THE PATIENT WAS IMPLANTED WITH:LIFECELL STRATTICE MESH, LOT NO. SP100622-095; (B)(6) 2018; (B)(6) 2019. WHEN THE PATIENT WAS IMPLANTED WITH LIFECELL STRATTICE MESH, LOT NO.: SP20009066; AND (B)(6) 2020, WHEN THE PATIENT WAS IMPLANTED WITH LIFECELL STRATTICE MESH, LOT NO: SP20022023. THIS RECORD IS ASSOCIATED WITH THE DEVICE IMPLANTED ON AUGUST 20, 2018; LOT SP100622-095. IT WAS ALSO REPORTED THE PATIENT WAS IMPLANTED WITH DEVICE LOT NO: SP20022023 ON (B)(6) 2020. HOWEVER ,THERE IS NO EVENT REPORTED AFTER THE IMPLANTATION AND THEREFORE AN ADDITIONAL COMPLAINT RECORD WILL NOT BE OPENED FOR SP20022023. IT SHOULD ALSO BE NOTED THIS IN AN INVALID LOT NUMBER. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR # 1000306051-2023-00100 ABBVIE COMPLAINT #

  Patient problems: Hernia

  MAUDE report 16871484 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) /2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE LOT ASSOCIATED WITH THIS EVENT WAS FOUND THROUGH DISCOVERY AND IS SP100185-137. NO OTHER INFORMATION WAS REPORTED. IT SHOULD BE NOTED THAT LOT S10911-046 WAS PROVIDED IN THE ORIGINAL SUMMONS; HOWEVER, BASED ON THE MANUFACTURER DATE, & DOS, IT IS MOST LIKELY THAT LOT SP100185-137 IS THE CORRECT LOT. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2015 AT (B)(6)HOSPITAL OF SURGERY IN (B)(6), OHIO. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH PRODUCT; LOT NUMBER S10911-046. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2016 AND UNDERWENT A MESH REVISION OPERATION. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: Hernia

  MAUDE report 16823138 ↗
• InjuryFeb 14, 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 PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2017. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. AFTER SURGERY, PATIENT RETURNED TO HOSPITAL ON OR ABOUT (B)(6) 2018, FOR A REVISION SURGERY.

  Patient problems: Hernia

  MAUDE report 16371737 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON (B)(6) 2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE LOT ASSOCIATED WITH THIS EVENT WAS FOUND THROUGH DISCOVERY AND IS SP100185-123. NO OTHER INFORMATION WAS REPORTED. AS REPORTED IN THE INITIAL: "IT WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2015. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2017 FOR A REVISION SURGERY."

  Patient problems: Hernia

  MAUDE report 16250921 ↗
• InjuryJan 26, 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 48YEAR OLD PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2021. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A STRATTICE10 CM X 10 CM HERNIA MESH, LOT NO. (B)(4) REFERENCE NO. 1010002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2021, FOR A REVISION SURGERY AND THE PATIENT WAS IMPLANTED WITH STRATTICE TISSUE MATRIX MESH, LOT NUMBER (B)(4) REFERENCE NO. 1016002. THE MESH FAILED, AND THE PATIENT RETURNED TO THE HOSPITAL FOR A SECOND REVISION SURGERY ON (B)(6) 2022. NO OTHER INFORMATION WAS REPORTED. THIS RECORD IS ASSOCIATED WITH (B)(4) IMPLANTED ON (B)(6) 2021,. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR # 1000306051-2023-00002 (ABBVIE COMPLAINT # (B)(4)).

  Patient problems: Hernia

  MAUDE report 16248772 ↗
• InjuryJan 3, 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 62 YEAR OLD FEMALE PATIENT HAD PARASTOMAL HERNIA REPAIR SURGERY ON (B)(6) 2016. DURING THE HERNIA REPAIR SURGERY, PLAINTIFF¿S SURGEON IMPLANTED A STRATTICE MESH IN HER; THE LOT AND BATCH NUMBERS FOR THAT MESH ARE (B)(4). THE CATALOG AND SERIAL NUMBERS FOR THAT MESH ARE 1010002. AFTER SURGERY, THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2017. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 16085953 ↗
• InjurySep 13, 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 45 YEAR OLD FEMALE HAD INCISIONAL HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2011. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE FIRM MESH, CATALOG 1010002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2012 AND WAS DIAGNOSED WITH A RECURRENT HERNIA AND NONHEALING SURGICAL WOUND. ON OR ABOUT (B)(6) 2012, THE PATIENT UNDERWENT BILATERAL MUSCULOCUTANEOUS ABDOMINAL WALL FLAP CONSTRUCTION, EXCISIONAL DEBRIDEMENT OF ABDOMINAL WALL SKIN, SUBCUTANEOUS TISSUE, FASCIA, AND PRIOR MESH. THE RECURRENT HERNIA WAS REPAIRED WITH THE PLACEMENT OF ADDITIONAL MESH.

  Patient problems: Hernia

  MAUDE report 15410017 ↗
• InjuryJul 28, 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 61 YEAR OLD PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2015. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE FIRM MESH. AFTER SURGERY, THE PATIENT HAD REVISION SURGERIES ON (B)(6) 2018 AND ON (B)(6) 2019.

  Patient problems: Hernia

  MAUDE report 15123359 ↗
• InjuryJun 16, 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 38 YEAR OLD MALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2017. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE FIRM MESH. AFTER SURGERY, THE PATIENT UNDERWENT AN EXPLANT SURGERY ON (B)(6) 2018, DURING WHICH ANOTHER STRATTICE MESH PRODUCT WAS IMPLANTED. THE RECORDS INDICATE THIS IS A STRATTICE FIRM MESH AS WELL. AFTER THAT SURGERY, THE PATIENT UNDERWENT SURGERY FOR A RECURRENT HERNIA ON (B)(6) 2019, AND ANOTHER EXPLANT SURGERY ON (B)(6) 2020. THIS RECORD IS ASSOCIATED WITH THE FIRST DEVICE IMPLANTED ON (B)(6) 2017 WITH EXPLANT DATE (B)(6) 2018.

  Patient problems: Hernia

  MAUDE report 14715913 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#2 TO REPORT PMQA WAS MADE AWARE 7/8/22 THAT THE DHR INVESTIGATION WAS PERFORMED ON THE WRONG LOT INADVERTENTLY AND THIS FOLLOW UP IS TO REPORT THE INVESTIGATION CONCLUSION ON THE CORRECT LOT. AS REPORTED IN FOLLOW UP#1: THIS IS FOLLOW UP# 1 TO REPORT ON JUNE 16, 2022, PMQA RECEIVED AN EMAIL FROM LEGAL THAT INDICATED THE SUBLOT NUMBER ASSOCIATED WITH THIS EVENT IS -075. THE SERIAL NUMBER HAS BEEN UPDATED TO (B)(6) . AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 49 YEAR OLD FEMALE PATIENT UNDERWENT OPEN REPAIR OF VENTRAL/INCISIONAL HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2020. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE FIRM MESH, ITEM 1010002, LOT SP200172 IN HER. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT JUNE 3, 2021 AND WAS DIAGNOSED WITH A RECURRENT VENTRAL HERNIA. ON OR ABOUT (B)(6) 2021, SHE UNDERWENT OPEN REPAIR OF RECURRENT VENTRAL/INCISIONAL HERNIA WITH MESH AND LEFT AND RIGHT MYOCUTANEOUS MUSCLE RELEASE FOR COMPONENT SEPARATION.

  Patient problems: Hernia

  MAUDE report 14437850 ↗
• InjuryApr 25, 2022Adverse 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 (B)(6) FEMALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2015. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A LIFECELL STRATTICE MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2015, WAS DIAGNOSED WITH A RECURRENT HERNIA AND UNDERWENT A MESH REVISION SURGERY.

  Patient problems: Hernia

  MAUDE report 14192247 ↗
• InjuryApr 4, 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 AN INCARCERATED UMBILICAL HERNIA REPAIR SURGERY ON (B)(6) 2018 AT GRAND STRAND MEDICAL CENTER. DURING THE SURGERY, THE SURGEON IMPLANTED STRATTICE MESH LOT SP100589-246, ITEM 1010002. ON (B)(6), 2019, THE PATIENT UNDERWENT SURGERY IN WHICH THE SECOND SURGEON: LYSED ADHESIONS BETWEEN THE MESH, OMENTUM, AND THE LOOP OF THE SMALL BOWEL, AND REMOVED THE MESH IN ITS ENTIRETY, RESECTED A PORTION OF THE SMALL BOWEL DUE TO CONCERN OF POSSIBLE FISTULA FORMATION.

  Patient problems: Adhesion(s); Fistula

  MAUDE report 13999120 ↗
• InjuryMar 2, 2022Adverse 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 UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2016 AND (B)(6) 2020. DURING THE PATIENT'S HERNIA REPAIR SURGERIES, THE SURGEON IMPLANTED STRATTICE MESH. THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2020. ON OR ABOUT (B)(6) 2020, THE PATIENT UNDERWENT A SMALL BOWEL RESECTION AND REMOVAL OF MESH. THIS RECORD IS ASSOCIATED WITH THE SECOND DEVICE IMPLANTED ON (B)(6) 2020.

  Patient problems: Hernia

  MAUDE report 13654510 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2013, (B)(6) 2015, (B)(6) 2016, (B)(6) 2017, (B)(6) 2017, AND (B)(6) 2018. THE PATIENT WAS A FEMALE BETWEEN THE AGES OF 38 AND 43 AT THE TIMES OF SURGERY. THE PATIENT WAS IMPLANTED WITH STRATTICE LOT SP100353-152, IMPLANTED ON (B)(6) 2016 (RECORD 3 OF 6). THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2018 AND (B)(6) 2019. ON (B)(6) 2018, THE PATIENT HAD LYSIS OF ADHESIONS AND REMOVAL OF THE MESH AND A HERNIA REPAIR AT (B)(6) MEDICAL CENTER. ON (B)(6) 2019 THE PATIENT HAD ANOTHER SURGERY REQUIRING ADDITIONAL REMOVAL OF THE STRATTICE MESH AT (B)(6) MEDICAL CENTER. THIS RECORD IS FOR THE DEVICE LOT SP100353-152, IMPLANTED ON (B)(6) 2016.

  Patient problems: Hernia

  MAUDE report 12218181 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL IMPLANTED A PIECE OF STRATTICE FIRM 10X10 IN PATIENT. THERE WERE NO COMPLICATIONS. PATIENT HAD A SUBSEQUENT SURGERY IN LATE JUNE. PATIENT CAME INTO THE CLINIC FOR A FOLLOW UP VISIT, AT WHICH TIME HEALTHCARE PROFESSIONAL FOUND WHAT THEY SUSPECT TO BE UNINCORPORATED STRATTICE PROTRUDING FROM THE INCISION.

  Patient problems: Foreign Body Reaction

  MAUDE report 10481919 ↗
• InjuryApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO INCARCERATED INGUINAL HERNIA, THE FEMALE PATIENT UNDERWENT VENTRAL HERNIA REPAIR WITH STRATTICE ON (B)(6) 2018. THE PATIENT PRESENTED WITH POSTOPERATIVE CELLULITIS. THE CAUSE OF THE CELLULITIS IS UNKNOWN AS THE SURGEON IS UNSURE IF THE REACTION IS RELATED TO THE STRATTICE. SURGICAL INTERVENTION TO REMOVE THE STRATTICE MESH WAS SCHEDULED BUT A DATE WAS NOT PROVIDED.

  Patient problems: Cellulitis

  MAUDE report 7432666 ↗