BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROSELECTRON HDR MODEL 105.999

    MDR report key: 490108 · Received October 15, 2003

    Report

    Report Number
    1121753-2003-00003
    Event Type
    Other
    Date Received
    October 15, 2003
    Date of Event
    September 8, 2003
    Report Date
    October 7, 2003
    Manufacturer
    NUCLETRON B.V.
    Product Code
    JAQ
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    AT THE COMPLETION OF THE 1ST OF 15 FRACTIONS FOR HDR BREAST BRACHYTHERAPY USING A MAMMOSITE APPLICATOR (MADE BY PROXIMA), THE IR-192 SOURCE DID NOT RETRACT TO THE SHIELDED POSITION. THE PHYSICIST TRIED TO MANUALLY CRANK THE SOURCE WITHOUT SUCCESS. THE PHYSICIAN DISCONNECTED THE TRANSFER TUBE AND APPLICATOR AND PLACED THE TRANSFER TUBE (WITH SOURCE) IN THE EMERGENCY CONTAINER. UNANTICIPATED RADIATION EXPOSURE WAS RECEIVED BY THE PT AND STAFF (ALBEIT LESS THAN THE MAXIMUM LIMITS IN STATE REGULATIONS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSELECTRON HDR MODEL 105.999 REMOTE CONTROLLED RADIOACTIVE APPLICATOR SYSTEM JAQ NUCLETRON B.V. MHD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other