BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLTENE/WHALEDENT INC.

    MDR report key: 5529138 · Received March 28, 2016

    Report

    Report Number
    2416455-2016-03002
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    February 25, 2016
    Report Date
    March 28, 2016
    Manufacturer
    COLTENE/WHALEDENT INC.
    Product Code
    FLG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    OFFICE PERSONNEL WALKED INTO THE ROOM AND OBSERVED THE UNIT ALREADY EMITTING A BLUE FLAME. NO SMOKE WAS OBSERVED (BUT THIS MAY HAVE OCCURRED PRIOR TO THE BLUE FLAME). INCIDENT OCCURRED AROUND MID DAY DURING A STANDARD CLEANING CYCLE, PERHAPS THE SECOND CYCLE OF THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186226 COLTENE/WHALEDENT INC. UC 95 ULTRASONIC CLEANER FLG COLTENE/WHALEDENT INC. BIOSONIC ULTRASONIC CLEANER

    Patients

    Seq Age Sex Outcome Treatment
    1