BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD MESH MONOFILAMENT KNITTED POLYPROPYLENE

    MDR report key: 250762 · Received November 22, 1999

    Report

    Report Number
    MW1017594
    Event Type
    Malfunction
    Date Received
    November 22, 1999
    Date of Event
    November 1, 1999
    Report Date
    November 12, 1999
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    MESH TORE WHILE ATTEMPTING TO SUTURE IT IN PLACE DURING REPAIR OF VENTRAL HERNIA. MESH WAS REMOVED AND REPLACED WITH SIMILAR ITEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD MESH MONOFILAMENT KNITTED POLYPROPYLENE Implant SIZE 3X6" FTL MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. * 1377037

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other