BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX COMP 3D PY 15CMCIR NO THRX1

    MDR report key: 2231490 · Received July 22, 2011

    Report

    Report Number
    9615742-2011-00063
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K040998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE INITIAL REPORT SENT: (B)(4) 2011.

    Description of Event or Problem · 1

    PROCEDURE TYPE: VENTRAL HERNIA REPAIR. ACCORDING TO THE REPORTER: THE MESH STARTED TO FRAY AND FALL APART. THE MESH KEPT TEARING WHEN TRYING TO PUT TACKS INTO IT TO HOLD IT IN PLACE. THE BARRIER WAS ALSO FALLING OFF VERY EASILY. THEY KEPT PUTTING TACKS IN AND IT EVENTUALLY HELD IN PLACE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO TISSUE DAMAGE OR UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX COMP 3D PY 15CMCIR NO THRX1 SURGICAL MESH FTL SOFRADIM PRODUCTION PKJ00328

    Patients

    Seq Age Sex Outcome Treatment
    1