BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 4360497 · Received December 18, 2014

    Report

    Report Number
    3002124545-2014-00037
    Event Type
    Injury
    Date Received
    December 18, 2014
    Date of Event
    November 27, 2014
    Report Date
    December 17, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LTD
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAD TWO TREATMENT DATES: (B)(6) 2014, LEFT LOBE 1.9 GBQ, AND (B)(6) 2014, RIGHT LOBE 2.7 GBQ. THE PT HAD LOTS OF SMALL LESIONS AND A HIGH TUMOR BURDEN BUT THE RESULTS WERE GOOD ON CT UNTIL (B)(6) 2014. ON THE (B)(6) 2014, THE PT WAS ADMITTED TO ANOTHER HOSP WITH ASCITES WHICH APPEARS TO BE RADIATION INDUCED LIVER FAILURE. THIS IS NOT CONFIRMED AND THE PT IS DUE TO BE TRANSFERRED TO THE FREEMAN FOR INVESTIGATION TO CONFIRM THIS ONE WAY OR THE OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830640 THERASPHERE YTTRIUM-90 MICROSPHERES NAW BIOCOMPATIBLES U.K. LTD 4990173, 4990215

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization