BEUDAMED
    FDA Adverse Event Other Summary report: N

    3D DIRECT DISPENSER GUN

    MDR report key: 770418 · Received October 13, 2006

    Report

    Report Number
    2082832-2006-00001
    Event Type
    Other
    Date Received
    October 13, 2006
    Date of Event
    September 18, 2006
    Report Date
    October 13, 2006
    Manufacturer
    S & C POLYMER GMBH
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE NOZZLE END OF THE RESIN CARPULE DISPENSER BURST OFF DURING USE IN A PT'S MOUTH. THE PT WAS STARTLED BY THE EVENT, BUT NOT INJURED. IT IS UNK IF COMPONENTS OF THE GUN HAD FALLEN INTO THE PT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D DIRECT DISPENSER GUN EID JTC S & C POLYMER GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other