BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 4144003 · Received October 3, 2014

    Report

    Report Number
    3002124545-2014-00025
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 3, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS COMPLAINT IS ONGOING AND FURTHER INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A PHYSICIAN CONTACTED A CLINICAL ACCOUNT MANAGER AND PROCTOR TO INFORM THEM THAT HIS RECENT THERASPHERE CASE, IT APPEARED THAT MOST OF THE DOSE HAD GONE TO THE GALLBLADDER INSTEAD OF THE LIVER TUMOR. THE PHYSICIAN HAD BEEN OBSERVING THE PATIENT AND SO FAR THE PATIENT HADN'T EXPERIENCED ANY ADVERSE EFFECTS. DURING FOLLOW UP BY THE PROCTOR ABOUT A WEEK LATER, THE PHYSICIAN STATED THERE WERE NO SIGNS OF CHOLECYSTITIS AT THIS TIME. THE PHYSICIAN WAS REMINDED OF THE PROTOCOL FOR ADMINISTERING CIPROFLOXACIN IF IT IS THOUGHT THAT THE CYSTIC ARTERY IS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617719 THERASPHERE YTTRIUM90 MICROSPHERES NAW BIOCOMPATIBLES U.K. LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other