BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSLUX® WAVE

    MDR report key: 7523112 · Received May 17, 2018

    Report

    Report Number
    3005665377-2018-00001
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Report Date
    April 27, 2018
    Manufacturer
    KULZER,LLC
    Product Code
    EBZ
    PMA / PMN Number
    K042199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION# E2013020, KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF KULZER GMBH (THE MANUFACTURER). THIS MALFUNCTION IS REPORTABLE ACCORDING TO 21 CFR 803. AS THIS SORT OF MALFUNCTION MAY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO REOCCUR. "MALFUNCTION" MEANS THE FAILURE OF A DEVICE TO MEET ITS PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED. THIS IS A SINGULAR EVENT. PRACTITIONER COMPLAINED OF SMELL OF BURNT PLASTIC. NEITHER PATIENT, PRACTITIONER NOR THIRD PARTY WAS INJURED, BUT WE ARE REPORTING OUT OF AN ABUNDANCE OF CAUTION. IF THIS WERE TO REOCCUR THE HEAT GENERATED MAY CAUSE INJURY.

    Description of Event or Problem · 0

    CURING LIGHT HAND PIECE HEATED UP, MELTED VOLTAGE METER ON PCB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365310 TRANSLUX® WAVE ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION EBZ KULZER,LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other