BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE 10 GBQ

    MDR report key: 319731 · Received March 6, 2001

    Report

    Report Number
    8022247-2001-00009
    Event Type
    Injury
    Date Received
    March 6, 2001
    Date of Event
    December 21, 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

    DIAGNOSED WITH COLORECTRAL CANCER IN 9/1998. PT PRESENTED FOR THERASPHERE TREATMENT WITH LIVER METASTASES. PT WAS TREATED OFF STUDY IN 2000 AND RECEIVED 143 GY ADMINISTERED TO THE ENTIRE LIVER. PT WAS DISCHARGED THE SAME DAY WITHOUT INCIDENT. IN 2000 PT WAS NEWLY DIAGNOSED WITH DIABETES WHICH RESPONDED WELL TO GLUCOVANCE. OVER THE PAST 2 WEEKS, PT PRESENTED WITH LETHARGY, SLEEPINESS, DECREASED MEMORY, PERSONALITY CHANGES, AND INABILITY TO BUTTON CLOTHES. PT PRESENTED YESTERDAY, BLOODWORK DRAWN AND PT, AS A RESULT, ADMITTED TO HOSP. AMMONIA 140 UMOL/L. PRINCIPAL INVESTIGATOR UNSURE IF THIS INCREASES RISK TO SUBJECTS. FURTHER INVESTIGATION IN PROGRESS AND FOLLOW-UP REPORT WILL FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9472 THERASPHERE 10 GBQ RADIOACTIVE GLASS MICROSPHERES KXK MDS NORDION, INC. * 990006

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization