BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIR-SPHERE

    MDR report key: 554038 · Received September 13, 2004

    Report

    Report Number
    MW1033224
    Event Type
    Malfunction
    Date Received
    September 13, 2004
    Date of Event
    September 1, 2004
    Report Date
    September 13, 2004
    Manufacturer
    SIRTEX MEDICAL INC.
    Product Code
    KXK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED FOR A SIR-SPHERE INFUSION FOR METASTATIC LIVER METASTASES. AFTER THE PROCEDURE, PT WAS FOUND TO HAVE RADIOACTIVE COUNTS -0.05 UCI/ML- ASSOCIATED WITH URINE. PT WAS CATHETERIZED AND STILL FOUND TO HAVE RADIOACTIVE COUNTS -0.05 UCI/ML- ASSOCIATED WITH URINE 2 HRS LATER -ALTHOUGH THE COUNTS WERE GREATLY DECREASED-. THE TEAM DISCUSSED THE CASE AND AS PT WAS ASYMPTOMATIC AND THE COUNTS WERE LOW, PT WAS ALLOWED TO COLLECT URINE OVERNIGHT. THE URINE SMAPLE IN THE MORNING HAD A RADIOACTIVE COUNT OF 0.066 UCI/ML-, AND PT WAS SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIR-SPHERE YTTRIUM-90 MICROSPHERES KXK SIRTEX MEDICAL INC. * 102314-003

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR