BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 621643 · Received July 15, 2005

    Report

    Report Number
    8022247-2005-00009
    Event Type
    Injury
    Date Received
    July 15, 2005
    Date of Event
    March 31, 2005
    Report Date
    June 15, 2005
    Manufacturer
    MDS NORDION
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2005 (15 DAYS POST-TREATMENT) THE PT WAS ADMITTED TO THE HOSP FOR DEHYDRATION, JUDGED POSSIBLY RELATED TO THERASPHERE. THE PT WAS GIVEN IV FLUIDS AND DISCHARGED IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERASPHERE RADIOACTIVE MICROSPHERES KXK MDS NORDION NI 5990011

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization