BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 8276507 · Received January 24, 2019

    Report

    Report Number
    9710358-2019-00001
    Event Type
    Death
    Date Received
    January 24, 2019
    Report Date
    January 3, 2019
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    NAW
    PMA / PMN Number
    P99065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMINISTERED 592 MBQ (16MCI) ON (B)(6) 2018. PATIENT PASSED AWAY SOON AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67919 SIR-SPHERES MICROSPHERES YTTRIUM 90 RESIN MICROSPHERES NAW SIRTEX MEDICAL LIMITED SIR-Y001

    Patients

    Seq Age Sex Outcome Treatment
    1 Death