BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM

    MDR report key: 14273399 · Received May 4, 2022

    Report

    Report Number
    1000306051-2022-00076
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    May 6, 2015
    Report Date
    May 2, 2022
    Product Code
    FTM
    UDI-DI
    00818410010140
    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 COMPLICATION WITH SURGICAL INTERVENTION. THE LOT ASSOCIATED WITH THIS EVENT WAS NOT REPORTED AND REMAINS UNKNOWN; THEREFORE A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. NO STRATTICE DEVICES WERE RETURNED FOR EVALUATION. BASED ON THE LIMITED INFORMATION REPORTED, A RELATIONSHIP BETWEEN THE EVENT AND STRATTICE CANNOT BE CONFIRMED. 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 (B)(6) MALE PATIENT UNDERWENT A PRIMARY VENTRAL HERNIA REPAIR ON OR ABOUT (B)(6) 2011. DURING THE SURGERY, THE SURGEON IMPLANTED STRATTICE MESH LOT B-10960, CATALOG 2020002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2015 AND WAS DIAGNOSED WITH ABSCESSES WHERE THE STRATTICE MESH WAS TACKED INTO PLACE. ON (B)(6) 2015, THE PATIENT HAD INCISION AND DRAINAGE OF ABDOMINAL CYSTS AND MESH REMOVAL. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074768 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM MESH, SURGICAL FTM NI 00818410010140

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention NO INFORMATION REPORTED