BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 1485062 · Received September 23, 2009

    Report

    Report Number
    MW5012839
    Event Type
    Injury
    Date Received
    September 23, 2009
    Date of Event
    September 16, 2009
    Report Date
    September 23, 2009
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN RF ENERGY TURNED ON, CATHETER DID NOT WORK. GENERATOR WOULD NOT COME ON. DOCTOR UNABLE TO TREAT AREA. ANOTHER CATHETER WAS OPENED AND USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER CATHETER DQO BIOSENSE WEBSTER 13326773

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention