BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE 20 GBQ

    MDR report key: 319774 · Received March 6, 2001

    Report

    Report Number
    8022247-2001-00004
    Event Type
    Injury
    Date Received
    March 6, 2001
    Date of Event
    September 25, 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 ON 9-00 FOR DIFFUSE ABDOMINAL PAIN, FEVER, CHILLS, NIGHT SWEATS & VOMITING. LOW HEMATOCRIT WAS NOTED UPON ADMISSION. CT-ABDOMEN SHOWED ASCITES (BLOODY) A POSSIBLE AREA OF LIVER NECROSIS. PARACENTESIS REVEALED FRANK BLOOD IN THE FLUID. THE PT RECEIVED 3 UNITS OF BLOOD. THE PT'S HEMATOCRIT RESPONDED TO THIS TREATMENT. RADIONUCLIDE ANGIOGRAM ON THE FOLLOWING DAY DID NOT IDENTIFY ANY SITE OF ACTIVE BLEEDING. NO ADD'L BLOOD PRODUCTS WERE NEEDED AND THE PT WAS DISCHARGED 7 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9415 THERASPHERE 20 GBQ RADIOACTIVE GLASS MICROSPHERES KXK MDS NORDION, INC. * 990003

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization