BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 196963 · Received October 30, 1998

    Report

    Report Number
    MW1014963
    Event Type
    Injury
    Date Received
    October 30, 1998
    Date of Event
    October 22, 1998
    Report Date
    October 29, 1998
    Manufacturer
    TOSHIBA AMERICAN MEDICAL SYSTEMS
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PREPPED AND DRAPPED. INITIAL INCISION MADE. NO X-RAY VISUALIZATION MADE. PROCEDURE ENDED AND PT TRANSFERRED TO NETWORK FACILITY, W/SHEATH INTACT PER AMBULANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA GENERATOR IZO TOSHIBA AMERICAN MEDICAL SYSTEMS KXO-200 A *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization