BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIR-SPHERES

    MDR report key: 586445 · Received March 29, 2005

    Report

    Report Number
    9710358-2005-00001
    Event Type
    Other
    Date Received
    March 29, 2005
    Report Date
    March 24, 2005
    Manufacturer
    SIRTEX MEDICAL LIMITED/LANE COVE BUSINESS PARK
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    10/2004, PT WAS FOUND TO HAVE UNRESECTABLE HEPATOCELLULAR CARCINOMA IN THE RIGHT LOBE. PT HAD PALLIATIVE TREATMENT WITH SIR-SPHERES TO ROGHT LOBE OF LIVER FOR HCC IN 2004, IN 1 1/2 MONTHS LATER, THE PT'S LEFT LOBE WAS TREATED. ON THE 3 MONTH FOLLOW UP FOR THE RIGHT LOBE AND THE ONE MONTH FOLLOW UP FOR THE LEFT LOBE, THE PT HAD A PLATELET COUNT OF 32,000. THE ONE MONTH FOLLOW UP FOR THE INTIAL TREATMENT, PLATELETS WERE 115,000. IN 2005, PT PRESENTED TO ED WITH SEVERE NOSEBLEEDS, FATIGUE, WEAKNESS, AND MILD NAUSEA WITHOU PAIN. THEY WERE ADMITTED FOR TREATMENT AND TESTING. THEY WERE DIAGNOSED WITH ACUTE MYELOCYTIC LEUKEMIA AND BONE MARROW BIOPSY 2 DAYS LATER. THE PT WAS DISCHARGED IN THE NEXT DAY TO FOLLOW UP WITH THEIR PRIMARY CARE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIR-SPHERES RADIOACTIVE BRACHYTHERAPY DEVICE KXK SIRTEX MEDICAL LIMITED/LANE COVE BUSINESS PARK SIR-Y001 102880

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other