BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSLUX POWER BLUE

    MDR report key: 649614 · Received November 22, 2005

    Report

    Report Number
    1925223-2005-00001
    Event Type
    Other
    Date Received
    November 22, 2005
    Date of Event
    October 21, 2005
    Report Date
    November 18, 2005
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EBZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTIST CALLED AND REPORTED THAT SHE RECEIVED THE TRANSLUX POWER BLUE UNIT A FEW WEEKS BEFORE THIS EVENT OCCURRED. WHEN HER DENTAL ASSISTANT PRESSED THE BUTTON TO TURN THE LIGHT ON, IT STARTED SMOKING AT THE BOTTOM OF THE HANDPIECE AND BURNED THROUGH THE DENTAL ASSISTANT'S GLOVE AND ONTO HER ARM SHE SAID YOU CAN SEE ON THE BACK OF THE HANDPIECE WHERE IT TURNED BLACK FROM BURNING. SHE STATED THAT HER DENTAL ASSISTANT WAS BURNED "PRETTY BAD" AND SHE FEELS BAD FOR HER. AN EVALUATION WAS INITIATED BY THE MANUFACTURER. HOWEVER CANNOT BE PROCESSED WITHOUT ADDITIONAL INFORMATION FROM THE INITIAL REPORTER. CONTACT HAS BEEN MADE TO OBTAIN THE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSLUX POWER BLUE ACTIVATOR, ULTRAVIOLET FOR POLYMERIZATION EBZ HERAEUS KULZER GMBH 66017507 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other