BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROSELECTRON-HDR (CLASSIC)

    MDR report key: 161556 · Received April 2, 1998

    Report

    Report Number
    1121753-1998-00005
    Event Type
    Other
    Date Received
    April 2, 1998
    Date of Event
    November 22, 1997
    Report Date
    February 20, 1998
    Manufacturer
    NUCLETRON BV
    Product Code
    JAQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    QUALITY ASSURANCE WITH NO PT PRESENT REVEALED THAT IN THE ABSENCE OF AN APPLICATOR IN CHANNEL 18, THE SOURCE LEFT THE SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSELECTRON-HDR (CLASSIC) REMOTE CONTROLLED RADIONUCLIDE APPLICATOR SYSTEM JAQ NUCLETRON BV M/HDR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other