BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES

    MDR report key: 443651 · Received January 20, 2003

    Report

    Report Number
    9710358-2003-00001
    Event Type
    Injury
    Date Received
    January 20, 2003
    Report Date
    January 20, 2003
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED A 2.5GBQ BRACHYTHERAPY IMPLANT OF SIR-SPHERES INTO THE LIVER VIA THE RIGHT HEPATIC ARTERY. PATIENT EXPERIENCED PERSISTENT RIGHT HYPOCHONDRIAL UPPER QUADRANT PAIN. RADIATION CHOLECYSTITIS WAS REPORTED FOLLOWING THE IMPLANT. SCANS SHOWED SPHERES IN THE GALL BLADDER (TO BE CONFIRMED). PATIENT UNDERWENT A CHOLECYSTECTOMY. SIR-SPHERES WERE SEEN WITHIN THE MUCOSA OF THE GALLBLADDER. RADIATION CHOLECYSTITIS IS NOT A KNOWN SIDE EFFECT OF SIR-SPHERES THERAPY AND THEREFORE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIR-SPHERES RADIOACTIVE BRACHYTHERAPY DEVICE KXK SIRTEX MEDICAL LIMITED SIR Y001 23601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization| R