BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 7916960 · Received September 27, 2018

    Report

    Report Number
    9710358-2018-00003
    Event Type
    Death
    Date Received
    September 27, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 15, 2018
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    NAW
    PMA / PMN Number
    P990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED RADIATION DUODENITIS AND GASTRITIS WITH LARGE GASTRIC ULCER, AND RADIATION HEPATITIS WHICH WAS ULTIMATELY FATAL. PATIENT DIED (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754913 SIR-SPHERES MICROSPHERES YTTRIUM 90 RESIN MICROSPHERES NAW SIRTEX MEDICAL LIMITED SIR-Y001 MC211

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O