BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER CATHETER

    MDR report key: 2316969 · Received October 25, 2011

    Report

    Report Number
    MW5022854
    Event Type
    Malfunction
    Date Received
    October 25, 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

    PHYSICIAN USED CATHETER IN CASE, BUT WAS "TORQUED" AND MALFUNCTIONED. BIOSENSE WEBSTER REP PRESENT IN CASE AND AWARE THAT CATHETER TO BE RETURNED FOR CREDIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER CATHETER LASSO NAV CATHETER DRF 15298467L

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR