BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIR-SPHERES

    MDR report key: 506235 · Received October 17, 2003

    Report

    Report Number
    506235
    Event Type
    Malfunction
    Date Received
    October 17, 2003
    Date of Event
    May 1, 2003
    Report Date
    August 1, 2003
    Manufacturer
    SIRTEX MEDICAL INC
    Product Code
    KPQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIR-SPHERES INTERNAL RADIATION MICROSPHERES KPQ SIRTEX MEDICAL INC * 35299-4

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR