BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROSELECTRON-HDR

    MDR report key: 161724 · Received April 2, 1998

    Report

    Report Number
    1121753-1998-00007
    Event Type
    Other
    Date Received
    April 2, 1998
    Date of Event
    November 13, 1997
    Report Date
    March 5, 1998
    Manufacturer
    NUCLETRON BV
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE DISTAL END (END CAP) OF VAGINAL CYLINDER DETACHED. USER REMOVED THE CAP FROM THE PATIENT AFTER THE APPLICATOR WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSELECTRON-HDR REMOTE CONTROLLED RADIONUCLIDE APPLICATOR SYSTEM JAQ NUCLETRON BV M/HDR (ACCESSORY) NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other