BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE 10 GBQ

    MDR report key: 319726 · Received March 6, 2001

    Report

    Report Number
    8022247-2001-00008
    Event Type
    Injury
    Date Received
    March 6, 2001
    Date of Event
    December 13, 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

    A PT WHO PRESENTED WITH PROGRESSIVE BREAST CANCER (ORIGINALLY DIAGNOSED 1992). THE PT PRESENTED FOR THERASPHERE TREATMENT WITH LIVER METASTASES. PT WAS TREATED IN 2000 AND RECEIVED APPROX 149 GY ADMINISTERED TO THE ENTIRE LIVER. PT WAS DISCHARGED THE SAME DAY WITHOUT INCIDENT. ON EVENT DATE PT PRESENTED WITH A COUGH WITH NO SHORTNESS OF BREATH AND NO PLEURITIC PAIN. PHYSICAL EXAM ON EVENT DATE REVEALED DECREASED BREATH SOUNDS IN THE RIGHT BASE. A CT SCAN REVEALED MODERATE SIZED RIGHT PLEURAL EFFUSION. PT WILL BE FOLLOWED IN 4 WEEKS TIME WITH CHEST X-RAY AND ABDOMINAL/PELVIC CT SCAN. THE CLINICIAN JUDGED THE PLEURAL EFFUSION TO BE POTENTIALLY RELATED TO THERASPHERE TREATMENT. THE PT WILL BE FOLLOWED CLOSELY TO MONITOR ANY CHANGES IN STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9523 THERASPHERE 10 GBQ RADIOACTIVE GLASS MICROSPHERES KXK MDS NORDION, INC. * 990006

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR