BEUDAMED
    FDA Adverse Event Summary report: N

    SIR-SPHERES

    MDR report key: 507723 · Received January 20, 2004

    Report

    Report Number
    9710358-2004-00001
    Date Received
    January 20, 2004
    Date of Event
    January 11, 2004
    Report Date
    January 20, 2004
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WITH METASTATIC LIVER COLON CARCINOMA; STATUS POST 7 CYCLES OF XELODA AT TREATMENT FACIITY. FOLLOW-UP CT THERAPY REVEALED ENLARGEMENT OF MULTIPLE HEPATIC LESIONS. PT REFERRED TO ANOTHER HOSP FOR SIR-SPHERES. TREATED WITH APPROX 53MCL IN 2003. NO ACTIVITY OF COLORECTAL METASTASES ON POST SIR-SPHERES TREATMENT PET TWO MONTHS PRIOR TO DEMISE. PT BECAME SHORT OF BREATH. WENT TO ANOTHER HOSP. TREATED WITH LACTULOSE FOR ELEVATED AMMONIUM. DIAGNOSED WITH LIVER FAILURE AND DISCHARGED 01/04 TO HOME. NO OTHER DETAILS AVAILABLE FROM HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIR-SPHERES RADIOACTIVE BRACHYTHERAPY DEVICE KXK SIRTEX MEDICAL LIMITED SIR-Y001 36299-LR

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death