BEUDAMED
    FDA Adverse Event Death Summary report: N

    Y-90 THERASPHERE (3 GBQ) CANADA COMM

    MDR report key: 12149833 · Received July 12, 2021

    Report

    Report Number
    2134265-2021-08778
    Event Type
    Death
    Date Received
    July 12, 2021
    Date of Event
    June 1, 2021
    Report Date
    August 6, 2021
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    E1: UPDATE TO INITIAL REPORTER INFORMATION. DATE OF EVENT: EVENT DATE IS UNKNOWN. THEREFORE, EVENT DATE IS ESTIMATED TO THE FIRST DAY OF THE MONTH THE BSC BECAME AWARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ASCITES AND DEATH OCCURRED. THE PATIENTS SISTER REPORTED TO THE CUSTOMER SUPPORT MAILBOX, THAT THE PATIENT DEVELOPED ASCITES AND PASSED AWAY POST THERASPHERE IMPLANT. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EVENT DATE IS UNKNOWN. THEREFORE, EVENT DATE IS ESTIMATED TO THE FIRST DAY OF THE MONTH THE BSC BECAME AWARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ASCITES AND DEATH OCCURRED. THE PATIENTS SISTER REPORTED TO THE CUSTOMER SUPPORT MAILBOX, THAT THE PATIENT DEVELOPED ASCITES AND PASSED AWAY POST THERMOSPHERE IMPLANT. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045692 Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Death