Strattice Reconstructive Tissue Matrix 1620002Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI M32816200020), received between Mar 4, 2019 and May 17, 2024 — classified as 37 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 reports).

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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 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) 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.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 19346849 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 02/FEB/2024, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM. PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2018. AS PER THE PPF FORM, THE PATIENT UNDERWENT A ¿PARASTOMAL HERNIA¿ SURGERY AND WAS IMPLANTED WITH 1ST STRATTICE DEVICE WITH CATALOG NUMBER 1016002 ON (B)(6) 2018. ON (B)(6) 2021, THE PATIENT UNDERWENT A ¿PARASTOMAL HERNIA¿ SURGERY AND WAS IMPLANTED WITH A SECOND STRATTICE DEVICE WITH CATALOG NUMBER 1620002. ON (B)(6) 2022, THE PATIENT UNDERWENT A ¿PARASTOMAL HERNIA¿ SURGERY AND WAS IMPLANTED WITH A THIRD STRATTICE DEVICE. THE PATIENT UNDERWENT AN ¿EXPLORATORY LAPAROTOMY WITH ADHESIOLYSIS > 3 HRS, REPAIR OF PARASTOMAL HERNIA WITH STRATTICE MESH, PARTIAL COLECTOMY WITH END COLOSTOMY, EXCISION OF MESH¿ ON (B)(6) 2021. THE PATIENT NEXT UNDERWENT A ¿PARASTOMAL HERNIA REPAIR WITH BIOLOGIC MESH¿ ON (B)(6) 2022. AS PER THE PPF FORM, THE PATIENT CLAIMS THE IMPLANTATION AND FAILURE OF THE MESH CAUSED ¿PAIN, PHYSICAL INJURY, SCARRING, DISFIGUREMENT.¿ PATIENT ¿HAS BEEN HOSPITALIZED AND UNDERGONE MULTIPLE SURGICAL PROCEDURES.¿ ¿IT TAKES [THE PATIENT] LONGER TO COMPLETE DAILY TASKS AND [PATIENT] IS DEPENDENT ON OTHERS TO HELP WITH DAILY TASKS [THEY HAVE] DIFFI

  Patient problems: Hernia

  MAUDE report 18764472 ↗
• 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 STRATTICE ON (B)(6) 2018. 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: Abscess; Adhesion(s); Hernia

  MAUDE report 17662438 ↗
• InjuryAug 29, 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 FIRM ON (B)(6) 2021. 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 17645934 ↗
• InjuryAug 29, 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 DEVICE LOT SP100276-199 ON (B)(6) 2016. THE PATIENT WAS TREATED FOR ¿PAIN¿, ¿RECURRENCE¿, ¿ADHESIONS¿, ¿INFECTION¿ AND UNDERWENT AN "ABDOMINAL WALL DEBRIDEMENT, ABDOMINAL WALL MESH EXPLANTATION, VENTRAL INCISIONAL HERNIA REPAIR (REDUCIBLE), NEGATIVE PRESSURE WOUND THERAPY (LARGE), AND WOUND CLOSURE SECONDARY ABDOMEN¿ ON (B)(6) 2019.

  Patient problems: Adhesion(s); Bacterial Infection; Hernia

  MAUDE report 17645777 ↗
• InjuryAug 1, 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 FIRM ON (B)(6) 2021. 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: Abscess; Hernia; Obstruction/Occlusion; Post Operative Wound Infection

  MAUDE report 17439258 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 12/SEPT /2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE 63-YEAR-OLD MALE PATIENT UNDERWENT AN ¿INCARCERARED RECURRENT VENTRAL HERNIA¿ REPAIR ON (B)(6) 2020 AND WAS IMPLANTED WITH STRATTICE MESH DEVICE LOT SP200136-022. THE PATIENT THEN UNDERWENT AN ¿IMAGE GUIDED ASPIRATION OF ANTERIOR ABDOMINAL WALL SEROMAS¿ ON (B)(6) 2020. THE PPF FORM ALSO INDICATES THE PATIENT WAS NOT IMPLANTED WITH ANY OTHER DEVICES. ADDITIONAL INFORMATION FROM THE MEDICAL RECORDS STATES THAT THE PATIENT HAS A PAST MEDICAL HISTORY OF SIGNIFICANT CORONARY ARTERY DISEASE STATUS POST TRIPLE BYPASS, HYPERTENSION, DYSLIPIDEMIA, STROKE, AND TIA. DURING THE INITIAL IMPLANT SURGERY ON (B)(6) 2020, THE WOUND CLASS WAS CLEAN-CONTAMINATED. THE ABDOMEN WOUND WAS IRRIGATED WITH COPIOUS AMOUNTS OF SALINE SOLUTION, AND THEY CLOSED THE FASCIA, SEWING IN THE STRATTICE MESH IN AN INTERRUPTED FASHION. A JP DRAIN WAS PLACED THROUGH THE SKIN ABOVE THE FASCIA TO AVOID ANY SEROMAS OR ABSCESS FORMATION. THE PATIENT PRESENTED TO THE ER A FEW TIMES SINCE THE HERNIA REPAIR. ON (B)(6) 2020, THE PATIENT PRESENTED

  Patient problems: Bacterial Infection; Hernia; Seroma

  MAUDE report 17217811 ↗
• InjuryJun 26, 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 PERFORATED ON (B)(6) 2020. 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 17202347 ↗
• InjuryMay 23, 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 55 YEAR OLD PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2016. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH, THE RECORDS INDICATE THIS IS A STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2020, FOR A REVISION SURGERY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 16986517 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT THE RESULTS FROM THE INTERNAL INVESTIGATION AND THE CONCLUSION. THE AWARE DATE IS BASED ON WHEN THE BATCH RECORD REVIEW WAS COMPLETED. AS REPORTED IN THE INITIAL: ON 4/6/2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE LOTS ASSOCIATED WITH (B)(4) WERE FOUND THROUGH DISCOVERY AND ARE "S11253-203 (ON (B)(6) 2014 IMPLANT) AND SP100155-231 (ON (B)(6) 2015 IMPLANT)". SINCE THE ORIGINAL LEGAL SUMMONS DID NOT INCLUDE INFORMATION THAT A SECOND DEVICE WAS IMPLANTED, PMQA FOLLOWED UP WITH LEGAL TO VERIFY. AS PER LEGAL ON 4/14/2023, "BASED ON OUR RECORDS, WE JUST KNOW THE PLAINTIFF RECEIVED ONE MESH ON (B)(6) 2014 AND A SECOND MESH ON (B)(6) 2015. PLAINTIFF IS ALLEGING REVISION/EXPLANT SURGERIES ON (B)(6) 2014, ON (B)(6) 2015, ON (B)(6) 2017 (SEE BELOW). ON (B)(6) 2014, CT-GUIDED PERCUTANEOUS ABSCESS DRAINAGE WITH CATHETER PLACEMENT. ON (B)(6) 2014: EXPLORATORY LAPAROTOMY, ABDOMINAL WASHOUT, RIGHT COLECTOMY, VENTRAL HERNIA REPAIR; ON (B)(6) 2015 L EXPLORATORY LAPAROTOMY, EXTENSIVE LYSIS OF ADHESIONS, TAKEDOWN OF A COLO CUTANEROUS FISTULA WITH RESECTION OF AN ILEOCOLONIC ANASTOMOSIS AND SMALL BOWEL RESECTION, ABDOMINAL WALL RECONSTRUCTION WITH STRATTICE MESH,

  Patient problems: Bacterial Infection; Hernia

  MAUDE report 16911758 ↗
• InjuryMay 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 PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2014. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH, LOT NUMBER S11250-503. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. AFTER SURGERY, PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2015, FOR A REVISION SURGERY. ON (B)(6) 2015, PATIENT HAD A SMALL BOWEL RESECTION AND REPAIR OF A VENTRAL HERNIA WITH ADDITIONAL STRATTICE MESH (LOT # SP100200-092 REF# (B)(4)) IMPLANTED. AFTER SURGERY, PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2016, FOR A REVISION AND REMOVAL SURGERY AND ADDITIONAL MESH WAS IMPLANTED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 1000306051-2023-00095 (ALLERGAN COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND DEVICE.

  Patient problems: Hernia

  MAUDE report 16860672 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL EVENT A FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT(B)(6) 2012 AT THE QUEEN'S MEDICAL CENTER IN HONOLULU. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH PRODUCT; LOT NUMBER S11045-041. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2015 AND UNDERWENT A MESH REVISION OPERATION. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: Hernia

  MAUDE report 16820260 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL EVENT THAT PLAINTIFF HAD A 52 YEAR OLD MALE PATIENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2016. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A LIFECELL - STRATTICE RECONSTRUCTIVE TISSUE MATRIX (TRM), LOT # SP100340-REF # 1620002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6), 2017, FOR A REVISION SURGERY AND ADDITIONAL MESH WAS IMPLANTED. NO OTHER INFORMATION WAS REPORTED. THERE IS NO OCCURRENCE REPORTED AFTER IMPLANTATION OF SECOND DEVICE AND NO INDICATION THE MESH WAS STRATTICE THEREFORE AN ADDITIONAL RECORD WILL NOT BE OPENED AT THIS TIME.

  Patient problems: Hernia

  MAUDE report 16795453 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 8/3/2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE LOT ASSOCIATED WITH THIS EVENT WAS FOUND THROUGH DISCOVERY AND IS (B)(6). NO OTHER INFORMATION WAS REPORTED. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 73 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2016. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2021, FOR A REVISION SURGERY. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: Hernia

  MAUDE report 16691204 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 14/APR/2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE LOT ASSOCIATED WITH THIS EVENT WAS FOUND THROUGH DISCOVERY AND IS S11072-144. NO OTHER INFORMATION WAS REPORTED. AS REPORTED IN INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 41 YEAR OLD MALE HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2012. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A 10CM X 15 CM STRATTICE HERNIA MESH (EX. MATRIX TISSUE STRATTICE HERNIA FIRM) MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2015, FOR A REVISION SURGERY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 16522760 ↗
• 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 ON (B)(6) 2017. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A TISSUE STRATTICE FIRM MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT ON (B)(6) 2017 AND ON (B)(6) 2019 FOR A REVISION SURGERY.

  Patient problems: Hernia

  MAUDE report 16371663 ↗
• 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 FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT ON (B)(6) 2019. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; LOT NUMBER: SP200040-098 AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT ON (B)(6) 2019 AND UNDERWENT A MESH REVISION OPERATION FOLLOWING A POSTOPERATIVE SEROMA. THE PATIENT RETURNED TO THE HOSPITAL FOR A SECOND FOLLOW-UP OPERATION ON (B)(6) 2019. IN THE SAME OPERATION, THE PHYSICIAN REPLACED THE STRATTICE WITH A SURGIMESH MESH. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 16268592 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT THE RESULTS FROM THE INTERNAL INVESTIGATION AND THE CONCLUSION. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 38 YEAR OLD FEMALE HAD HERNIA REPAIR SURGERY ON (B)(6) 2012. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE LOT AND BATCH NUMBER FOR THIS MESH IS S1106061-172. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2013. SHE WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA. THE REMAINING STRATTICE MESH WAS REMOVED AND ADDITIONAL MESH WAS IMPLANTED. ON OR ABOUT (B)(6) 2015, THE PATIENT PRESENTED WITH A RECURRENT INCARCERATED VENTRAL INCISIONAL HERNIA AND ADDITIONAL STRATTICE WAS IMPLANTED. SHE UNDERWENT A SERIES OF ADDITIONAL REVISION SURGERIES, WITH STRATTICE BEING REMOVED ON OR AROUND (B)(6) 2016. ON OR ABOUT (B)(6) 2021, THE PATIENT PRESENTED WITH A RECURRENT VENTRAL HERNIA THAT WAS REPAIRED WITH STRATTICE. THE CATALOG NUMBER FOR THIS MESH IS 1620002 AND THE LOT NUMBER IS SP200133-040. NO OTHER INFORMATION WAS REPORTED. THIS RECORD IS ASSOCIATED WITH THE DEVICE IMPLANTED (B)(6) 2015; LOT UNKNOWN. ALTHOUGH IT WAS REPORTED THERE WAS PLACEMENT OF AN ADDITIONAL MESH DURING THE (

  Patient problems: Hernia

  MAUDE report 16184036 ↗
• InjuryDec 5, 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 FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2016. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL FOR REVISION/EXPLANT SURGERIES ON OR ABOUT (B)(6) 2016, (B)(6) 2016, (B)(6) 2017, AND (B)(6) 2018. NO OTHER INFORMATION AS PROVIDED.

  Patient problems: Hernia

  MAUDE report 15920343 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEPTEMBER 7TH, 2022, ABBVIE PMQA RECEIVED NOTIFICATION THROUGH THE FDA ORIGINATED LETTERS SYSTEM OF MEDSUN MANDATORY AND VOLUNTARY MEDWATCH REPORT FORM (B)(4). THE REPORT WAS SUBMITTED BY THE SPECIALIST RISK MANAGEMENT AND SAFETY PERSON AT THE REPORTED FACILITY. THE REPORT STATES "65 YEAR OLD MALE PATIENT WHO WEIGHED 83 KG UNDERWENT LIVER TRANSPLANT. PATIENT RETURNED TO OR A FEW DAYS LATER FOR ABDOMINAL WALL CLOSURE WITH STRATTICE MESH. THIS IS ONE OF TWO CASES WHERE THERE WAS POSSIBLE STRATTICE MESH CONTAMINATION WHICH RESULTED IN POST-OPERATIVE INFECTIONS OF IMMUNOCOMPROMISED TRANSPLANT PATIENTS. OR CULTURES GREW A MULTIDRUG RESISTANT ORGANISMS (MDRO) AND FUNGUS. THE ORIGINAL INTENDED PROCEDURE WAS LISTED AS LIVER TRANSPLANT. RELEVANT HISTORY WAS REPORTED TO HAVE INCLUDED PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: IMMUNO-COMPROMISED. THE DEVICE LOT ASSOCIATED WITH THIS EVENT IS SP200379-029 WITH DATE OF EVENT AS (B)(6) 2022. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ON 9/14/22, PMQA RECEIVED ADDITIONAL INFORMATION FROM THE MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A TRANSPLANT BRING BACK LIVER; FASCIAL CLOSURE WITH BRIDGING OF STRATICE ON (B)(6

  Patient problems: Fungal Infection

  MAUDE report 15529037 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, ABBVIE PMQA RECEIVED NOTIFICATION THROUGH THE FDA ORIGINATED LETTERS SYSTEM OF MEDSUN MANDATORY AND VOLUNTARY MEDWATCH REPORT FORM 0301030000-2022-8005. THE REPORT WAS SUBMITTED BY THE SPECIALIST RISK MANAGEMENT AND SAFETY PERSON AT THE REPORTED FACILITY. THE REPORT STATES "61 YEAR OLD MALE PATIENT WHO WEIGHED 71 KGS UNDERWENT SIMULTANEOUS LIVER-KIDNEY TRANSPLANT. MULTIPLE RETURNS TO OR FOR COMPLICATIONS. STRATTICE MESH PLACED TEN DAYS AFTER TO CLOSE ABDOMINAL WALL. THIS CASE AND ANOTHER POST-TRANSPLANT/MESH CASE ARE POSSIBLE MESH DEVICE INFECTIONS. OR CULTURES GREW MULTIDRUG RESISTANT ORGANISMS (MDRO) AND FUNGUS." THE ORIGINAL INTENDED PROCEDURE WAS LISTED AS LIVER-KIDNEY TRANSPLANT RELEVANT HISTORY WAS REPORTED TO HAVE INCLUDED PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: IMMUNO-COMPROMISED; SURGERY. THE DEVICE LOT ASSOCIATED WITH THIS EVENT IS (B)(4) WITH DATE OF EVENT AS (B)(6) 2021. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ON (B)(6) 2022, PMQA RECEIVED ADDITIONAL INFORMATION FROM THE MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A TRANSPLANT BRING BACK LIVER WITH PLANNED ABDOMINAL CLOSURE WITH STRATICE BIOPROSTHETIC, ABDOMINAL WASHOU

  Patient problems: Fungal Infection

  MAUDE report 15528807 ↗
• InjuryAug 26, 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 58 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2015. DURING THE HERNIA REPAIR SURGERY THE SURGEON IMPLANTED A STRATTICE MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2016 FOR A MESH REMOVAL OPERATION.

  Patient problems: Hernia

  MAUDE report 15300543 ↗
• 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 SEPTEMBER 26, 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 SECOND DEVICE IMPLANTED ON (B)(6) 2018.

  Patient problems: Hernia

  MAUDE report 14715998 ↗
• InjuryMay 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 (B)(6) FEMALE PATIENT UNDERWENT A PARASTOMAL HERNIA REPAIR SURGERY ON (B)(6) 2017. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED STRATTICE LOT SP100472-089, CATALOG 1620002 MESH IN HER. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2018 AND WAS DIAGNOSED WITH A RECURRENT PARASTOMAL HERNIA AND ILEOSTOMY PROLAPSE. ON (B)(6) 2018, SHE HAD AN EXPLORATORY LAPAROTOMY WITH LYSIS OF ADHESIONS, EXPLANTATION OF MESH, ILEOSTOMY REVERSAL WITH SMALL BOWEL RESECTION AND PARASTOMAL HERNIA REPAIR.

  Patient problems: Hernia

  MAUDE report 14345689 ↗
• InjuryMay 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 FEMALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2008. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE FIRM MESH IN HER. THE LOT NUMBER FOR THAT MESH IS S1D088, CATALOG NUMBER FOR THAT MESH IS 1620002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2012 WITH COMPLAINTS OF ABDOMINAL PAIN. SHE WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA. ON OR ABOUT (B)(6) 2012 SHE UNDERWENT A REVISION SURGERY FOR REPAIR OF RECURRENT INCISIONAL HERNIA WITH MESH AND REMOVAL OF FOREIGN BODY, WHICH WAS THE PREVIOUSLY PLACED STRATTICE MESH. DURING THE PROCEDURE, HER SURGEON NOTED MULTIPLE INTRA-ABDOMINAL ADHESIONS BETWEEN THE OMENTUM AND ANTERIOR ABDOMINAL WALL, FASCIAL DEFECT, AND TOTALLY DISLODGED THE OLD MESH WHICH WAS DISSECTED OFF. IT SHOULD BE NOTED THE LOT NUMBER PROVIDED IS NOT POPULATING AS A VALID LOT, THEREFORE, THE LOT ASSOCIATED WITH THIS EVENT IS UNKNOWN. THE CATALOG/ITEM NUMBER IS VALID.

  Patient problems: Hernia

  MAUDE report 14274156 ↗