BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM

    MDR report key: 21267332 · Received January 29, 2025

    Report

    Report Number
    1000306051-2025-00007
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    November 2, 2021
    Report Date
    April 25, 2025
    Manufacturer
    LIFECELL
    Product Code
    FTM
    UDI-DI
    00818410010393
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT ASSOCIATED WITH THIS EVENT WAS NOT REPORTED AND REMAINS UNKNOWN; THEREFORE A REVIEW INTO THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. NO STRATTICE DEVICES WERE RETURNED FOR EVALUATION. BASED ON THE LIMITED INFORMATION, AND WITHOUT RELEVANT PATIENT FACTORS, A RELATIONSHIP BETWEEN THE EVENT AND THE STRATTICE COULD NOT BE DETERMINED. DUE TO THE LEGAL PROCESS, IF ADDITIONAL INFORMATION IS MADE AVAILABLE DURING LEGAL PROCEEDINGS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD FOR STRATTICE LOT SP100555 HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. WITHOUT RELEVANT PATIENT FACTORS, A RELATIONSHIP BETWEEN THE STRATTICE AND THIS EVENT COULD NOT BE DETERMINED. DUE TO THE LEGAL PROCESS, IF ADDITIONAL INFORMATION IS MADE AVAILABLE DURING LEGAL PROCEEDINGS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH 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.

    Description of Event or Problem · 0

    THIS IS FOLLOW UP#1 TO REPORT ON 22/APR/2025, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM (PPF). AS PER THE PPF FORM, THE PATIENT UNDERWENT A REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIORRHAPHY WITH AN INLAY BIOLOGIC MESH, EXTENSIVE LYSIS OF ADHESIONS, REMOVAL OF INTRA-ABDOMINAL MESH WITH A BILATERAL COMPONENT SEPARATION PROCEDURE, BILATERAL COMPONENTS SEPARATION MUSCLE FLAP HERNIA CLOSURE, REPAIR OF VENTRAL HERNIA, PLACEMENT OF MESH IN HERNIA, USE OF BIOLOGIC MESH FOR REINFORCEMENT OF HERNIA REPAIR WITH STRATTICE DEVICE LOT# SP100555059, REF. #2030002 ON (B)(6) 2019. ON (B)(6) 2021, REPAIR INCISIONAL HERNIA WITH MESH (NON ABBVIE DEVICE, PROGRIP LOT #SVD0560X). THE FORM LISTS THE CONDITION THAT WAS TREATED: (B)(6) 2019, RECURRENT VENTRAL INCISIONAL HEMIORRHAPHY WITH AN INLAY BIOLOGIC MESH, EXTENSIVE LYSIS OF ADHESIONS, REMOVAL OF INTRA- ABDOMINAL MESH WITH A BILATERAL COMPONENT SEPARATION PROCEDURE BILATERAL COMPONENTS SEPARATION MUSCLE FLAP HERNIA CLOSURE, REPAIR OF VENTRAL HERNIA, PLACEMENT OF MESH IN HERNIA, USE OF BIOLOGIC MESH FOR REINFORCEMENT OF HERNIA REPAIR. (B)(6) 2019, WORSENING ABDOMINAL PAIN; CT: STATUS POST MESH REPAIR ALONG THE ANTERIOR ABDOMINAL WALL WITH INDURATION OF THE SUBCUTANEOUS FAT OF THE ANTERIOR ABDOMINAL WALL AND RECTUS MUSCLES. (B)(6) 2021, WORSENING ABDOMINAL PAIN, NAUSEA; DIAGNOSTIC TESTING; CT AB/PEL: RIGHT VENTRAL HERNIA WITH SMALL BOWEL CONTENTS. (B)(6) 2021, REPAIR INCISIONAL HERNIA WITH A NON-ABBVIE MESH (PROGRIP LOT #SVD0560X). (B)(6) 2021, ABDOMINAL PAIN; CT AB/PEL: RIGHT LOWER QUADRANT, SUBCUTANEOUS ENCAPSULATED COLLECTION IDENTIFIED COULD REPRESENT A SEROMA. APPROX. 2015-2021/2022, PRIMARY CARE; DEPRESSION AND ANXIETY; ABDOMINAL PAIN; HERNIA SYMPTOMS; POST-OP. 2021/2022-2024, PRIMARY CARE, ABDOMINAL PAIN, DEPRESSION AND ANXIETY. (B)(6) 2018-2019, ABDOMINAL PAIN; HERNIA SYMPTOMS, HERNIA REPAIR, POST-OP. (B)(6) 2018-2019, ABDOMINAL PAIN; REEVALUATION OF VENTRAL INCISIONAL HERNIA; DIAGNOSTIC TESTING; HERNIA SYMPTOMS, HERNIA REPAIR; POST-OP. (B)(6) 2021-2022, HERNIA SYMPTOMS, RECURRENT HERNIA; PREP FOR HERNIA REPAIR; CT SCANS/IMAGING; HERNIA REPAIR; HERNIA FOLLOW-UP. (B)(6) 2025, ABDOMINAL PAIN. AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781195 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM MESH, SURGICAL FTM LIFECELL SP100555 00818410010393

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention