BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 2316961 · Received October 25, 2011

    Report

    Report Number
    MW5022856
    Event Type
    Malfunction
    Date Received
    October 25, 2011
    Date of Event
    September 28, 2011
    Report Date
    October 25, 2011
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MAGNET SENSOR IN CATHETER NOT WORKING. REPLACED WITH NEW CATHETER. REP WAS PRESENT IN THE DEPARTMENT AND TOOK CATHETER TO REPLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER BIOSENSE NAVISTAR J CURE CATHETER DRF 15368485M

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR