BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM

    MDR report key: 15410017 · Received September 13, 2022

    Report

    Report Number
    1000306051-2022-00145
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    August 21, 2012
    Report Date
    September 13, 2022
    Product Code
    FTM
    UDI-DI
    00818410010096
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. THE LOT ASSOCIATED WITH THIS EVENT WAS NOT REPORTED AND REMAINS UNKNOWN; THEREFORE AN INTERNAL INVESTIGATION INTO THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. NO STRATTICE DEVICES WERE RETURNED FOR EVALUATION. BASED ON THE LIMITED INFORMATION, INCLUDING NO IDENTIFICATION OF THE LOT NUMBER, 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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665586 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL FTM NI 00818410010096

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention NO INFORMATION