Strattice Reconstructive Tissue Matrix 2025002Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI M32820250020), received between Apr 5, 2021 and Mar 17, 2025 — classified as 23 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 11/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 A STRATTICE DEVICE ON (B)(6) 2020. THE PATIENT UNDERWENT A ¿REPAIR OF RECURRENT INCISIONAL HERNIA WITH MESH¿ ON (B)(6) 2022. AS PER THE PPF FORM, THE PATIENT CLAIMS THE IMPLANTATION AND FAILURE OF THE MESH CAUSED THE FOLLOWING INJURIES: ¿PHYSICAL INJURY, LOSS OF ENJOYMENT OF LIFE, AND ECONOMIC AND NON-ECONOMIC LOSSES AS A RESULT OF [THEIR] STRATTICE IMPLANT. [THE PLAINTIFF] IS DEPENDENT ON OTHERS TO HELP WITH TASKS [THEY HAVE] DIFFICULTY COMPLETING [THEMSELVES.] THESE INJURIES CONTRIBUTE TO [THE PLAINTIFF¿S] ANXIETY AND DEPRESSION.¿ THE FORM LISTS THE CONDITIONS THAT WERE TREATED WERE ¿EXTENSIVE LYSIS OF ADHESIONS, SMALL BOWEL RESECTIONS X3, PARTIAL TRANSVERSE COLECTOMY, GASTROJEJUNOSTOMY BILLROTH II, EXCISION OF ABDOMINAL WALL SCAR AND INFECTED MESH, ABDOMINAL RECONSTRUCTION WITH COMPONENT SEPARATION CREATING SKIN FLAPS, CARE OF AN INCISIONAL HERNIA WITH STRATUS MESH; ENTEROCUTANEOUS FISTULA¿ BETWEEN (B)(6) 2020. THE PATIENT WAS THEN TREATED FOR ¿NAUSEA, VOMITI

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

  MAUDE report 21620933 ↗
• 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)(60 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 2ND STRATTICE MESH.

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

  MAUDE report 20971971 ↗
• InjuryAug 15, 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 FIRM ON (B)(6) 2018 AND 2ND STRATTICE FIRM ON (B)(6) 2019. 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). THIS EMDR IS BEING SUBMITTED FOR THE 2ND STRATTICE FIRM.

  Patient problems: Abscess; Fistula; Hernia; Post Operative Wound Infection

  MAUDE report 19996350 ↗
• InjuryJun 13, 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) 2016. 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 19533440 ↗
• InjuryMay 10, 2024Adverse 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) 2024, 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 A STRATTICE DEVICE LOT 810667-302 AND CATALOG 2025002 ON (B)(6) 2010. THE PATIENT UNDERWENT A ¿REMOVAL OF MESH + INJURY (ADHESIONS, PAIN) TO REPAIR RECURRENT INCISIONAL HERNIA¿ ON (B)(6) 2011. THE FORM LISTS THE CONDITIONS THAT WAS TREATED WAS ¿HERNIA¿ IN 2010 AND 2011. THE PPF FORM ALSO INDICATES THAT THE PATIENT WAS IMPLANTED WITH A NON-ABBVIE DEVICE, ¿BARD/DAVOL: SEPRAMESH IP (LOT: UNKNOWN),¿ ON (B)(6) 2011. THE FORM INDICATES THAT THE DEVICE WAS REMOVED ON (B)(6) 2022 DUE TO ¿ADHESIONS, FISTULA, INFECTION, MESH EXPOSED, AND WOUND VAC TO REPAIR INCISIONAL HERNIA.¿ THE PATIENT RECEIVED TREATMENT FOR ¿HERNIA¿ RELATED TO THIS DEVICE IN 2011 AND 2022. AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2010. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICAT

  Patient problems: Adhesion(s); Hernia

  MAUDE report 19287275 ↗
• 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 STRATTICE FIRM ON (B)(6) 2022. 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; Obstruction/Occlusion

  MAUDE report 19248830 ↗
• InjuryApr 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 STRATTICE FIRM MESH ON (B)(6) 2010. 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: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Obstruction/Occlusion

  MAUDE report 19140845 ↗
• InjuryApr 16, 2024Adverse 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) 2024, 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 1ST STRATTICE DEVICE LOT #S11286-085 AND REF. #(B)(4) ON (B)(6) 2014. ON (B)(6) 2016, PATIENT UNDERWENT A REPAIR OF INCARCERATED RECURRENT INCISIONAL HERNIA WITH BIOLOGIC MESH (2ND STRATTICE DEVICE) LOT #SP100380-011, REF. #(B)(4). ON (B)(6)2016, PATIENT UNDERWENT AN INCISION & DRAINAGE & DEBRIDEMENT OF ABDOMINAL WALL ABSCESS WITH INTRAABDOMINAL COMPONENT, REMOVAL OF PIECE OF STRATTICE BIOLOGIC MESH THAT WAS FLOATING IN ABSCESS CAVITY. ON (B)(6) 2018, RECURRENT INCISIONAL HERNIA REPAIR WITH STRATUS GRAFT, EXTENSIVE LYSIS OF ADHESIONS, AND PATIENT WAS IMPLANTED WITH 3RD STRATTICE DEVICE LOT #SP100480, REF. #(B)(4). DEBRIDEMENT WAS PERFORMED ON (B)(6) 2019. ON (B)(6) 2019, REMOVED FIBRIN SLOUGH & EXUDATE & NECROTIC SUBCUTANEOUS TISSUE FOR EXCISIONAL DEBRIDEMENT. ON (B)(6) 2019, PATIENT UNDERWENT A MANUAL REDUCTION OF EVISCERATED SMALL BOWEL, REPAIR OF LATERAL DEHISCENCE OF CHRONIC NONHEALING LOWER ABDOMINAL WOUND WITH STRATTICE MESH (4TH ST

  Patient problems: Fluid Discharge; Hernia; Impaired Healing; Necrosis; Wound Dehiscence

  MAUDE report 19122001 ↗
• InjuryOct 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) 2013. 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); Bacterial Infection; Hernia

  MAUDE report 18043996 ↗
• InjuryJun 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 28/AUG/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 INCISIONAL HERNIA REPAIR WITH ADHERENE, EROSION OF SMALL BOWEL INTO PREVIOUS MESH; EXPLORATORY LAPAROTOMY; MID SMALL BOWEL RESECTION AND PERFORMANCE OF SIDE-BY-SIDE STAPLED ANASTOMOSIS FOLLOWING A SMALL BOWEL ENTEROTOMY; EXPLANTATION OF PREVIOUS PERIUMBILICAL MESH¿ AND ¿REPAIR OF VENTRAL INCISIONAL HERNIA¿ WITH STRATTICE MESH DEVICE LOT SP200147-104 ON (B)(6) 2020. THE PPF FORM ALSO LISTS ADDITIONAL CONDITIONS TREATED AS ¿EVALUATION OF ABDOMINAL BULGE WITH PAIN WHEN TOUCHED; CT ABD/PELVIS - LARGE VENTRAL MIDLINE ABDOMINAL WALL HERNIA CONTAINING LOOPS OF PREDOMINANTLY SMALL BOWEL¿ IN (B)(6) 2020. ¿RECURRENT INCISIONAL HERNIA; RECOMMENDED AN OPEN, RETRORECTUS INCISIONAL HERNIA REPAIR WITH SYNTHETIC MESH PLACED IN A PREPERITONEAL POSITION; GROWTH AND PAIN AT SITE; NAUSEA¿ ON (B)(6) 2021. ¿SUPRAPUBIC PAIN AND DIFFICULTY WITH URINATION; CONTINUATION OF NON-SURGICAL ABDOMEN WITH REDUCIBLE HERNIA¿ ON (B)(6) 2021. THE PATIENT THEN UNDERWENT AN ¿OPEN REPAIR OF RECURRENT VENTRAL HERNI

  Patient problems: Adhesion(s); Hernia

  MAUDE report 17199090 ↗
• 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) 2013. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH, LOT NUMBER S11268-035. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. AFTER SURGERY, PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2014 FOR A REMOVAL AND REVISION SURGERY.

  Patient problems: Bacterial Infection; Hernia

  MAUDE report 16860662 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM THE SALES REP ON BEHALF OF THE HCP THAT REPORTED A STRATTICE 20X25CM WAS PREVIOUSLY IMPLANTED IN A BRIDGE/INLAY FASHION. AS PER THE HCP, ¿THE STRATTICE AT THE FASCIA MARGINS LOOKED GREAT AND FIXATED AND WHAT WAS PRESENT THRU THE CENTER HAD GROWN INTO THE BOWEL AND WAS THINNED, THEN SEPARATED AND PULLED OF A SECTION OF SMALL BOWEL CAUSING A LEAK.¿ NO OTHER INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s)

  MAUDE report 16638502 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#2 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 FOLLOW UP#1: "ON 11/MAY/2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE LOTS ASSOCIATED WITH THIS EVENT WERE FOUND THROUGH DISCOVERY AND ARE SP100567-015, IMPLANT DATE (B)(6)2019 AND SP200083-376, IMPLANT DATE (B)(6) 2020. 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) 2019. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. PATIENT HAD A SUBSEQUENT STRATTICE MESH IMPLANTED DURING A HERNIA REPAIR SURGERY ON (B)(6) 2020. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. PATIENT UNDERWENT A REVISION SURGERY ON (B)(6)2021. THIS RECORD IS FOR THE 1ST STRATTICE MESH."

  Patient problems: Hernia

  MAUDE report 16250968 ↗
• 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 55 YEAR OLD FEMALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2014. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. AFTER SURGERY, THE PATIENT HAD REVISION SURGERIES ON (B)(6) 2017, AND (B)(6) 2017. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Bacterial Infection; Fistula; Hernia

  MAUDE report 16086688 ↗
• 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 46 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) 2015, AND (B)(6) 2015, DEBRIDEMENT OF NECROTIC TISSUE & CHRONIC OPEN ABDOMINAL WOUNDS. THE PATIENT THEN RETURNED TO THE HOSPITAL ON (B)(6) 2016, FOR A REVISION SURGERY. NO OTHER INFORMATION PROVIDED.

  Patient problems: Hernia; Necrosis

  MAUDE report 15852120 ↗
• InjuryOct 27, 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 MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2018. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE FIRM MESH; THE MODEL/CATALOGUE NUMBER IS 2025002 AND THE LOT NUMBER IS SP100401-055. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2019 FOR A REVISION SURGERY. ON (B)(6) 2019, HE UNDERWENT OPEN RECURRENT HERNIA REPAIR, LYSIS OF ADHESIONS, RESECTION OF FISTULOUS TRACK, AND EXPLANT OF MESH.

  Patient problems: Hernia

  MAUDE report 15685333 ↗
• InjurySep 12, 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 MALE PATIENT UNDERWENT A VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2016. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE FIRM MESH IN HIM, LOT SP100388-058, CATALOG 2025002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2017 FOR A REVISION SURGERY.

  Patient problems: Hernia

  MAUDE report 15406722 ↗
• 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 41 YEAR OLD MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2010. DURING THE HERNIA REPAIR SURGERY THE SURGEON IMPLANTED A STRATTICE MESH. AFTER SURGERY THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2017 FOR A REVISION SURGERY. THE PATIENT RETURNED TO THE HOSPITAL AGAIN ON (B)(6) 2017, FOR A SURGERY DURING WHICH HIS PHYSICIAN IMPLANTED ANOTHER STRATTICE MESH. FOLLOWING THE SECOND IMPLANT, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2021 FOR ANOTHER REVISION PROCEDURE. THIS RECORD IS ASSOCIATED WITH THE DEVICE IMPLANTED ON (B)(6) 2017.

  Patient problems: Hernia

  MAUDE report 15300530 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO PS BY THE LEGAL DEPARTMENT THAT A PATIENT UNDERWENT HERNIA REPAIR AND IMPLANTED WITH STRATTICE ON (B)(6) 2017. THERE WERE OTHER REVISION SURGERIES ON (B)(6)2018 AND (B)(6) 2019. NO OTHER INFORMATION WAS REPORTED. THE LOT (S) ASSOCIATED WITH THIS COMPLAINT REMAINS UNKNOWN.

  Patient problems: Hernia

  MAUDE report 14346383 ↗
• 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 (B)(6) MALE PATIENT UNDERWENT INCARCERATED VENTRAL AND INCISINIONAL HERNIA REPAIR SURGERY ON OR ABOUT (B)(6), 2012. DURING THE SURGERY, THE SURGEON IMPLANTED A STRATTICE FIRM MESH, CATALOG 2025005. AFTER SURGERY, 5 YEARS LATE, THE PATIENT RETURNED TO THE HOSPITAL ON OR AROUND (B)(6) 2017 AND WAS DIAGNOSED WITH INFECTED MESH. ON OR AROUND (B)(6), 2017, THE PATIENT HAD AN EXPLORATORY LAPAROTOMY AND INFECTED UNINCORPORATED MESH REMOVAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection

  MAUDE report 14274246 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED THROUGH LEGAL, THAT A (B)(6) MALE PATIENT UNDERWENT HERNIA REPAIR SURGERY AND WAS IMPLANTED WITH STRATTICE LOTS SP100461-147 AND SP100388-001 ON (B)(6) 2016. ON (B)(6) 2019 THE PATIENT HAD A REPAIR OF THE RECURRENT VENTRAL HERNIA WITH COMPONENT SEPARATION AND REMOVAL OF PREVIOUSLY PLACED MESH. THIS RECORD IS ASSOCIATED WITH LOT SP100461-147 - RECORD 1 OF 2.

  Patient problems: Hernia

  MAUDE report 12752468 ↗
• InjuryJun 9, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPRESENTATIVE REPORTED A MALE PATIENT HAD STRATTICE, 2025002, IMPLANTED ON (B)(6) 2017 FOR A VENTRAL HERNIA REPAIR. PATIENT WAS HOSPITALIZED ON (B)(6) 2018 AND A REVISION SURGERY TOOK PLACE FOR A BOWEL OBSTRUCTION AND HERNIA REVISION ON B)(6) 2018 . LOT NUMBER SP100477-004.

  Patient problems: Hernia; Obstruction/Occlusion

  MAUDE report 11968061 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY VENTRAL INCISIONAL HERNIA REPAIR SURGERY AND STATTICE MESH IMPLANTED. PATIENT RETURNED TO THE HOSPITAL 3 YEARS LATER AND WAS DIAGNOSED WITH PARTIAL SMALL-BOWEL OBSTRUCTION AND A RECURRENT VENTRAL INCISIONAL HERNIA WITH INCARCERATION. MESH REMOVED.

  Patient problems: Hernia; Obstruction/Occlusion

  MAUDE report 11614906 ↗