Strattice Reconstructive Tissue Matrix 1016002Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI M32810160020), received between Jun 7, 2021 and Feb 16, 2026 — classified as 40 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 10/MAR/2026, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED.AS PER THE PPF FORM, THE PATIENT UNDERWENT A RECURRENT VENTRAL HERNIA SURGERY WITH A STRATTICE DEVICE LOT #SP100273-220, REF. #1016002P ON (B)(6) 2015. ON (B)(6) 2023, PATIENT UNDERWENT ROBOTIC LYSIS OF ADHESIONS AND EXCISION OF PREVIOUSLY PLACED MESH. ROBOTIC ASSISTED LAPAROSCOPIC RECURRENT VENTRAL HERNIA REPAIR WITH MESH. THE AFFECTED STRATTICE WAS REMOVED AND REPLACED WITH A NON-ABBVIE DEVICE, BARD VENTRALIGHT ST, LOT NUMBER HUGY0866. AS PER THE PPF FORM, THE PATIENT CLAIMS "CONTRACTED AND ROLLED MESH; DENSE ADHESIONS TO BOWEL WITH 90 MINUTES LYSIS; RECURRENCE." AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2015. 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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia

  MAUDE report 24349588 ↗
• InjuryMar 14, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THIS IS FOLLOW UP#1 TO REPORT ON 14/AUG/2025, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT UNDERWENT AN ¿INCISIONAL HERNIA¿ SURGERY AND WAS IMPLANTED WITH TWO STRATTICE DEVICES ON (B)(6) 2018. THE PATIENT UNDERWENT AN ¿INCISION & DRAINAGE OF ABDOMINAL WALL ABSCESS, DEBRIDEMENT¿ ON (B)(6) 2019. THE PATIENT UNDERWENT AN ¿ABSCESS DRAINAGE/INCISION & DRAINAGE¿ ON (B)(6) 2021. THE PATIENT UNDERWENT AN ¿INCISION & DRAINAGE¿ ON (B)(6) 2021. THE PATIENT UNDERWENT A ¿NON-HEALING SUTURE ABSCESS, SUTURE REMOVAL, ABSCESS CAVITY DEBRIDED¿ ON (B)(6) 2021. THE FORM LISTS THE CONDITIONS THAT WERE TREATED WERE ¿OPEN INCISIONAL HERNIA REPAIR (2-LAYER SANDWICH MESH REPAIR WITH STRATTICE AND A PRIMARY FASCIA CLOSURE); ABSCESS CAVITY DEBRIDED¿ BETWEEN (B)(6) 2018. THE PATIENT WAS THEN TREATED FOR ¿INCISION & DRAINAGE OF ABDOMINAL WALL ABSCESS; DEBRIDEMENT¿ ON (B)(6) 2019. THE PATIENT RECEIVED TREATMENT FOR ¿ABDOMINAL WALL PAIN; ABDOMINAL WALL ABSCESS; ABSCESS DRAINAGE/INCISION & DRAINAGE¿ ON OR ABOUT (B)(6) 2021. THE PATIENT RECEIVED ¿INCISION & DRAINAGE; CHRONIC ABDOMINAL WOUND INFECTION; SUTURE ABSCESS

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Post Operative Wound Infection

  MAUDE report 21612584 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 28/MAR/2025, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM (PPF). AS PER THE PPF FORM, THE PATIENT UNDERWENT RECURRENT INCARCERATED INCISIONAL HERNIA SURGERY AND WAS IMPLANTED WITH THE STRATTICE DEVICE LOT# SP100392-141 AND REF. #(B)(4) ON (B)(6) 2016. ON (B)(6) 2018, PATIENT UNDERWENT SMALL-BOWEL RESECTION, PRIMARY ANASTOMOSIS, EXTENSIVE LYSIS OF ADHESIONS, REMOVAL OF PRIOR MESH AND REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA WITH A NON-ABBIVE DEVICE, PHASIX MESH (LOT #HUBY1146). THE FORM LISTS THE CONDITION THAT WAS TREATED: (B)(6) 2016 - REDUCTION AND REPAIR (STRATTICE) OF INCISIONAL HERNIA WITH SMALL BOWEL REPAIR AND EXTENSIVE LYSIS OF ADHESIONS. (B)(6) 2018 - ABDOMINAL PAIN, EVALUATION OF SBO; CT AB/PEL SCAN-SMALL BOWEL OBSTRUCTION SECONDARY TO VENTRAL HERNIA CONTAINING BOTH SMALL AND LARGE BOWEL. (B)(6) 2018 - ABDOMINAL PAIN; SMALL-BOWEL RESECTION, PRIMARY ANASTOMOSIS, EXTENSIVE LYSIS OF ADHESIONS, REMOVAL OF PRIOR MESH AND PHASIX MESH REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA. ON (B)(6) 2014, PATIENT WAS IMPLANTED WITH A NON-ABBVIE DEVICE, VENTRALIGHT ST, LOT #HUYB0394. ON (B)(6) 2016, VENTRALIGHT ST ME

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Obstruction/Occlusion

  MAUDE report 21345558 ↗
• InjuryDec 18, 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 1ST STRATTICE MESH ON (B)(6) 2015 AND 2ND STRATTICE MESH 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. THIS IS THE PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6), (EMDR-(B)(4). THIS EMDR IS BEING SUBMITTED FOR THE 1ST STRATTICE MESH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Obstruction/Occlusion

  MAUDE report 20971860 ↗
• InjuryAug 20, 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) 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: Adhesion(s); Hernia

  MAUDE report 20001808 ↗
• InjuryMay 6, 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 1ST STRATTICE ON (B)(6) 2015 AND 2ND STRATTICE FIRM 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 PATIENT IDENTIFIER CN-082626 (EMDR-31327). THIS EMDR IS BEING SUBMITTED FOR THE 2ND STRATTICE FIRM.

  Patient problems: Abscess; Hernia; Purulent Discharge; Seroma

  MAUDE report 19249750 ↗
• InjuryApr 16, 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 MATRIX FIRM STRATTICE ON (B)(6) 2012 WITH CATALOG NUMBER 1016002. PLAINTIFF UNDERWENT A REPAIR OF RECURRENT INCISIONAL VENTRAL HERNIA WITH UNDERLAY MESH ON OR ABOUT (B)(6) 2014. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION.

  Patient problems: Hernia

  MAUDE report 19122003 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT 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

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion

  MAUDE report 18360313 ↗
• InjuryNov 2, 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: Adhesion(s); Hernia

  MAUDE report 18054122 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 07/DEC/2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT UNDERWENT A ¿VENTRAL HERNIA¿ SURGERY AND WAS IMPLANTED WITH STRATTICE DEVICE CATALOG 1016002 ON (B)(6) 2018. THE PATIENT UNDERWENT A "MESH EXCISION, SMALL BOWEL RESECTION¿ ON (B)(6) 2021. AS PER THE PPF FORM, THE PATIENT CLAIMS THE IMPLANTATION AND FAILURE OF THE MESH CAUSED ¿ADHESIONS, INFLAMMATION, BOWEL COMPLICATIONS AND OBSTRUCTION, INTENSE CHRONIC PAIN, MENTAL ANGUISH ATTRIBUTED TO PAIN, AND MENTAL AND EMOTIONAL DISTRESS ATTRIBUTED TO BOWEL COMPLICATIONS¿. THE FORM LISTS THE CONDITIONS THAT WERE TREATED WERE ¿ADHESIONS, INFLAMMATION, BOWEL OBSTRUCTION AND COMPLICATIONS, AND CHRONIC PAIN¿ WITH APPROXIMATE DATES OF TREATMENT BETWEEN (B)(6) 2021. THE FORM ALSO LISTS ADDITIONAL TREATMENT FOR ¿ABDOMINAL PAIN¿ WITH APPROXIMATE DATES OF TREATMENT BETWEEN (B)(6) 2021 AND FOR ¿ADHESIONS, CHRONIC PAIN, ERYTHEMATOUS SMALL BOWEL¿ WITH APPROXIMATE DATES OF TREATMENT BETWEEN (B)(6) 2022. THE PPF FORM ALSO INDICATES THE PATIENT WAS IMPLANTED WITH NON-ABBVIE DEVICES, "PARIETEX, PARIETEX, SYMBOTEX¿ ON (B)(6) 2016. THE SYMBOTEX WAS REVIS

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion

  MAUDE report 17773536 ↗
• InjuryJul 27, 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/SEPT /2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT UNDERWENT AN ¿VENTRAL HERNIA¿ REPAIR ON (B)(6) 2021 AND WAS IMPLANTED WITH STRATTICE MESH DEVICE LOT SP200327-114. THE PATIENT THEN UNDERWENT AN ¿REPAIR OF RECURRENT VENTRAL HERNIA WITH LYSIS OF ADHESIONS AND REMOVAL OF PREVIOUSLY PLACED MESH¿ ON (B)(6) 2022. THE PPF FORM ALSO INDICATES THE PATIENT WAS IMPLANTED WITH NON-ABBVIE DEVICE ¿ETHICON PROLENE¿ DURING THE (B)(6) 2022 PROCEDURE. NO ¿REVISION OR REMOVAL¿ SURGERY WAS REPORTED FOR THE NON-ABBVIE DEVICE. THE PATIENT CLAIMS THE IMPLANTATION OF THE STRATTICE MESH HAS CAUSED ¿CHRONIC PAIN, ADHESIONS AND A HERNIA RECURRENCE WHICH REQUIRED AN ADDITIONAL SURGICAL PROCEDURE DURING WHICH THE STRATTICE WAS PARTIALLY REMOVED.¿ NO OTHER INFORMATION WAS PROVIDED. AS REPORTED IN THE INITIAL: 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 INDIC

  Patient problems: Adhesion(s); Hernia

  MAUDE report 17408559 ↗
• InjuryJun 29, 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 PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT UNDERWENT A ¿VENTRAL HERNIA¿ REPAIR ON (B)(6) 2017 AND WAS IMPLANTED WITH STRATTICE MESH DEVICE LOT (B)(4). THE PATIENT THEN UNDERWENT A ¿REPAIR OF RECURRENT VENTRAL HERNIA WITH REMOVAL OF PREVIOUSLY PLACED MESH¿ ON (B)(6) 2022. THE PPF FORM ALSO INDICATES THE PATIENT WAS IMPLANTED WITH NON-ABBVIE DEVICES, "ETHICON PROCEED¿ ON (B)(6) 2015, TWO ¿ETHICON PROCEED¿ DEVICES ON (B)(6) 2015, ¿COVIDIEN SYMBOTEX¿ ON (B)(6) 2019 AND TWO ¿TELA BIO OVITEX¿ DEVICES ON (B)(6) 2022 WHICH WERE ALL PERFORMED BY THE SAME SURGEON. NO ¿REVISION¿ OR ¿REMOVAL¿ WAS REPORTED FOR THE NON-ABBVIE DEVICES. THE PATIENT CLAIMS THE IMPLANTATION AND FAILURE OF THE STRATTICE MESH HAS ¿CAUSED CHRONIC PAIN, AND HERNIA RECURRENCE WHICH REQUIRED AN ADDITIONAL SURGICAL PROCEDURE DURING WHICH THE STRATTICE WAS REMOVED.¿ NO OTHER INFORMATION WAS PROVIDED. AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON APRIL 7, 2017. THE FORM ALSO INDICATES THAT ON AN U

  Patient problems: Hernia

  MAUDE report 17230534 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP# TO REPORT THE RESULTS FROM THE INTERNAL INVESTIGATION AND THE CONCLUSION. AS REPORTED IN THE INITIAL: DURING THE LOT RECONCILIATION ON (B)(6) 2023 FOR LEGAL EVENT (B)(4), IT WAS IDENTIFIED THROUGH DISCOVERY THAT THIS PATIENT WAS ALSO IMPLANTED WITH SP100121-080 ON (B)(6) 2014, ALTHOUGH THE ORIGINAL SUMMONS DID NOT REPORT A SECOND STRATTICE DEVICE WAS IMPLANTED. THE ORIGINAL SUMMONS REPORTS: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 51 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2013. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A STRATTICE 10 X 16 CM MESH. AFTER SURGERY, THE PATIENT HAD A REVISION SURGERIES ON (B)(6) 2014, AND (B)(6) 2016. NO OTHER INFORMATION WAS PROVIDED. SINCE THE PATIENT UNDERWENT A REVISION SURGERY IN (B)(6) 2016 AFTER THE SECOND DEVICE WAS IMPLANTED, THIS RECORD WAS OPENED TO CAPTURE THE EVENT OF ASSUMED RE-HERNIATION AND IS ASSOCIATED WITH LOT SP100121-080. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR # 1000306051-2022-00227 (ABBVIE COMPLAINT # (B)(4)).

  Patient problems: Hernia

  MAUDE report 16945092 ↗
• 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 SP100350, IMPLANTED (B)(6) 2017. DUE TO SYSTEM LIMITATION, THE LOT HAS BEEN DEFAULTED TO UNKNOWN, HOWEVER, LOT SP100350 IS A VALID LOT AND AN INVESTIGATION WILL BE PERFORMED ON LOT SP100350. 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 WIL

  Patient problems: Unspecified Infection

  MAUDE report 16872877 ↗
• InjuryMay 2, 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) 2012 AT (B)(6) MEDICAL CENTER IN (B)(6). DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH PRODUCT, LOT NUMBER S11086-120. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2013 AND UNDERWENT A MESH REVISION OPERATION. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: Hernia

  MAUDE report 16855311 ↗
• InjuryMar 20, 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 66 YEAR OLD MALE PATIENT HAD PRIMARY RECURRENT INCARCERATED INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2015.DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH; SP100291-183 - 1016002.AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2019AND WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA AND HAD EXTENSIVE LYSIS OF ADHESIONS AND MESH REMOVAL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 16573185 ↗
• InjuryFeb 17, 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 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; LOT # SP100409, REF # 1016002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2020 FOR A REVISION SURGERY. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: Hernia

  MAUDE report 16396125 ↗
• 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 48 YEAR OLD PATIENT HAD HERNIA REPAIR SURGERY ON (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 (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 # 1000306051-2023-00001. (ABBVIE COMPLAINT # (B)(4)).

  Patient problems: Hernia

  MAUDE report 16249833 ↗
• InjuryJan 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 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. ON OR ABOUT (B)(6) 2017, PATIENT UNDERWENT A MESH REVISION OPERATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 16235608 ↗
• InjuryJan 13, 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: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 4 YEAR OLD PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2020. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A LIFECELL ¿ STRATTICE MESH (LOT # SP200216-091 REF # 1016002) . AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2021, FOR A REVISION SURGERY AND ADDITIONAL STRATTICE MESH WAS IMPLANTED (LOT # SP200229-146 REF # 1010005). NO OTHER INFORMATION WAS REPORTED. ALTHOUGH A SECOND DEVICE WAS IMPLANTED; THERE IS NO REPORTED EVENT OCCURRENCE AFTER THE IMPLANT SURGERY; THEREFORE A SECOND COMPLAINT WAS NOT OPENED.

  Patient problems: Hernia

  MAUDE report 16158749 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL EVENT THAT MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2017. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE, LOT NUMBER SP100350-088. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2022, WITH A BOWEL OBSTRUCTION AND MULTIPLE INCARCERATED HERNIAS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 16125469 ↗
• InjuryJan 6, 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 51 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2013. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A STRATTICE 10 X 16 CM MESH. AFTER SURGERY, THE PATIENT HAD A REVISION SURGERIES ON (B)(6) 2014, AND (B)(6) 2016. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 16112130 ↗
• 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 MALE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2010. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE; THE RECORDS INDICATE THIS IS A STRATTICE FIRM MESH; THE LOT AND BATCH NUMBERS FOR THAT MESH ARE S16582-181. THE CATALOG AND SERIAL NUMBERS FOR THAT MESH ARE (B)(4). AFTER SURGERY, THE PATIENT HAD A REVISION/REMOVAL SURGERY ON APRIL 13, 2010. DURING THAT SURGERY, THE SURGEON IMPLANTED A SECOND STRATTICE MESH IN HIM. THE RECORDS INDICATE THIS IS A STRATTICE FIRM MESH. THE LOT AND BATCH NUMBERS FOR THAT MESH ARE S10807-161. THE CATALOG AND SERIAL NUMBERS FOR THAT MESH ARE (B)(4). ON (B)(6) 2011, THE PATIENT HAD A REVISION/REMOVAL SURGERY. NO OTHER INFORMATION WAS PROVIDED. THIS RECORD IS ASSOCIATED WITH THE DEVICE IMPLANTED ON (B)(6) 2010; LOT S16582-181. ALTHOUGH A LOT NUMBER WAS REPORTED, S16582-181 IS NOT A VALID LOT NUMBER.

  Patient problems: Hernia

  MAUDE report 16086777 ↗
• InjuryNov 23, 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 29 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2019. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2020, FOR A REVISION SURGERY.

  Patient problems: Hernia

  MAUDE report 15852307 ↗
• InjuryOct 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 59 YEAR OLD FEMALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2013. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH, LOT NUMBER IS S11166 AND REF NUMBER IS 1620002. ON OR ABOUT (B)(6) 2015, THE PATIENT UNDERWENT SURGERY FOR A CHRONIC SEROMA OF THE ABDOMINAL WALL AND INFECTION. PART OF THE MESH WAS CUT OUT AND THE SEROMA CAVITY WAS EXCISED. ON OR ABOUT (B)(6) 2015, THE PATIENT PRESENTED WITH A LARGE RECURRENT HERNIA AND UNDERWENT ANOTHER HERNIA REPAIR SURGERY WHERE THE SURGEON IMPLANTED ANOTHER STRATTICE MESH. THE RECORDS INDICATE THIS IS A LIFECELL MATRIX STRATTICE FIRM MESH, THE LOT NUMBER IS (B)(4) AND CATALOG NUMBER IS 1620002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2018 AND UNDERWENT A BILATERAL COMPONENT SEPARATION, EXPLANT OF PRIOR MESH, DEBRIDEMENT OF ABDOMINAL WALL, AND RECURRENT HERNIA REPAIR WITH IMPLANT OF ANOTHER STRATTICE MESH. THE RECORDS INDICATE THE MESH IMPLANTED IN (B)(6) 2018 IS A LIFECELL STRATTICE PERFORATED MESH. THE LOT NUMBER IS SP100567 AND THE CATALOG NUMBER IS 1620002P. THIS RECORD IS ASSOCIATED WITH (B)(4), IMPLANTED (B)(6) 2015 WITH DATE

  Patient problems: Hernia

  MAUDE report 15595551 ↗