BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT

    MDR report key: 1220494 · Received November 4, 2008

    Report

    Report Number
    3006260740-2008-00187
    Event Type
    Injury
    Date Received
    November 4, 2008
    Report Date
    October 10, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    EMBOLIZATION OF THE CATHETER AFTER THREE MONTHS. RADIOLOGICAL REMOVAL FROM THE RIGHT VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention