BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSLUX WAVE

    MDR report key: 6797994 · Received August 16, 2017

    Report

    Report Number
    3005665377-2017-00002
    Event Type
    Malfunction
    Date Received
    August 16, 2017
    Report Date
    July 17, 2017
    Manufacturer
    KULZER, GMBH
    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). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE MALFUNCTIONED, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. BECAUSE THE MALFUNCTION ALLEGATION COULD NOT BE CONFIRMED, THE CAUSE OF THE PRODUCT PROBLEM COULD NOT YET BE DETERMINED.

    Description of Event or Problem · 0

    THIS OCCURRED IN (B)(6). INITIAL COMPLAINT WAS THAT TRANSLUX WAVE CURING LIGHT DID NOT FUNCTION. UPON EXAMINATION, IT BECAME EVIDENT THAT THE PROTECTIVE COVER ON THE BATTERY HAD BEEN UNWRAPPED BY THE END USER.

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW UP REPORT. MANUFACTURER EVALUATED RETURNED CURING LIGHT AND DETERMINED DEVICE MAY OVERHEAT IF POLARITY IS REVERSED BY INVERSION. THE DEVICE IN QUESTION SHOWED EVIDENCE OF BEING INVERTED.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT. MANUFACTURER EVALUATED RETURNED CURING LIGHT AND DETERMINED DEVICE MAY OVERHEAT IF POLARITY IS REVERSED BY INVERSION. THE DEVICE IN QUESTION SHOWED EVIDENCE OF BEING INVERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579708 TRANSLUX WAVE ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION EBZ KULZER, GMBH 66055012

    Patients

    Seq Age Sex Outcome Treatment
    1