BEUDAMED
    FDA Adverse Event Death Summary report: N

    RUSCH

    MDR report key: 405833 · Received July 19, 2002

    Report

    Report Number
    8040412-2002-00146
    Event Type
    Death
    Date Received
    July 19, 2002
    Report Date
    July 16, 2002
    Manufacturer
    RUSCH SDN. BHD.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT 1/2 OF THE CATHETER BROKE OFF IN-PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH UROLOGICAL KOD RUSCH SDN. BHD. NA 02A07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN