BEUDAMED
    FDA Adverse Event Death Summary report: N

    Y-90 THERASPHERE (3 GBQ)

    MDR report key: 12234475 · Received July 27, 2021

    Report

    Report Number
    2134265-2021-09556
    Event Type
    Death
    Date Received
    July 27, 2021
    Date of Event
    January 7, 2020
    Report Date
    July 27, 2021
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MEDWATCH # MW5102307. IT WAS REPORTED THAT CARDIAC ARREST AND DEATH OCCURRED. THE PATIENT RECEIVED Y-90 THERASPHERE MICROSPHERES. CARDIAC ARREST AND DEATH OCCURRED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129894 Y-90 THERASPHERE (3 GBQ) MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Death