BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBOSPHERE MICROSPHERES

    MDR report key: 414947 · Received September 4, 2002

    Report

    Report Number
    1226551-2002-00007
    Event Type
    Death
    Date Received
    September 4, 2002
    Date of Event
    June 3, 2002
    Report Date
    September 4, 2002
    Manufacturer
    BIOSPHERE MEDICAL S.A./BAT A - PARC DES NATIONS
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE FIELD THAT A PATIENT HAD DIED IN THE RECOVERY ROOM AFTER UNDERGOING EMBOLIZATION THERAPY FOR TREATMENT OF METASTATIC ADRENAL CORTICAL TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSPHERE MICROSPHERES ARTIFICIAL EMBOLIZATION DEVICE HCG BIOSPHERE MEDICAL S.A./BAT A - PARC DES NATIONS 40-120,100-300,300-500 MICRONS UNKNOWN - MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death