BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE 20 GBQ

    MDR report key: 319770 · Received March 6, 2001

    Report

    Report Number
    8022247-2001-00002
    Event Type
    Injury
    Date Received
    March 6, 2001
    Date of Event
    September 20, 2000
    Report Date
    March 1, 2001
    Manufacturer
    MDS NORDION, INC.
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED 09-00 FOR ABDOMINAL PAIN, NAUSEA AND ANOREXIA. PT HAS HAD INTERMITTENT ABDOMINAL PAIN SINCE THEIR THERASPHERE TREATMENT. PT HAS NO HISTORY OF ULCER DISEASE. PHYSICAL EXAM SHOWED EPIGASTRIC AND RIGHT UPPER QUADRANT TENDERNESS. PT WAS TREATED WITH IV FLUIDS, IV MORPHINE (09-20-00) AND IV ZANTAC. AN ABDOMINAL CT-SCAN SHOWED NO CHANGE FROM THE PREVIOUS CT-SCAN. THE PAIN RESOLVED, AND THE PT WAS DISCHARGED THE FOLLOWING DAY ON MORPHINE SOLUTION AS NEEDED AND AXID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9454 THERASPHERE 20 GBQ RADIOACTIVE GLASS MICROSPHERES KXK MDS NORDION, INC. * 990004

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization