BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE 10 GBQ

    MDR report key: 319748 · Received March 6, 2001

    Report

    Report Number
    8022247-2001-00005
    Event Type
    Injury
    Date Received
    March 6, 2001
    Date of Event
    October 1, 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 COMPLAINED OF RIGHT-SIDED WEAKNESS ON 10-00. PT SUBSEQUENTLY BECAME CONFUSED, DISORIENTED AND NON-COMMUNICATIVE. PT WAS SEEN IN EMERGENCY ROOM WHERE A CT SCAN DID NOT SHOW ACTIVE HEMORRHAGE. PT'S BLOOD WORK WITHIN NORMAL LIMITS WITH MINOR ABNORMALITIES IN THE LIVER FUNCTION PANEL. EXAM BY NEUROLOGY CONFIRMED A DENSE RIGHT HEMIPLEGIA WITH GLOBAL APHASIA. PT CURRENTLY ON LOVENOX (60 MG SC BID) FOR PROPHYLAXIS OF RECURRENT DVT. PT IS SCHEDULED TO UNDERGO MRI IN 10-00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9450 THERASPHERE 10 GBQ RADIOACTIVE GLASS MICROSPHERES KXK MDS NORDION, INC. * 990005

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization