BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 838789 · Received April 11, 2007

    Report

    Report Number
    MW1042554
    Event Type
    Injury
    Date Received
    April 11, 2007
    Date of Event
    March 26, 2007
    Report Date
    March 29, 2007
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STEERING MECHANISM IN CATHETER STOPPED WORKING- CATHETER REPLACED. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER CATHETER DRF BIOSENSE WEBSTER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention