BEUDAMED
    FDA Adverse Event Summary report: N

    TRANSLUX® WAVE

    MDR report key: 5408267 · Received February 3, 2016

    Report

    Report Number
    3005665377-2016-00001
    Date Received
    February 3, 2016
    Date of Event
    January 12, 2016
    Report Date
    January 12, 2016
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EBZ
    PMA / PMN Number
    K042199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION# E2013020, HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER GMBH (THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, 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 ADVERSE REACTION COULD NOT BE DETERMINED. THIS IS CLASSIFIED AS A NEAR INCIDENT IN THAT THE TIMELY INTERVENTION OF STAFF WILL PREVENT ANY SERIOUS DAMAGE OR IMPAIRMENT TO THE RECEPTIONIST'S PHYSICAL STATE. DEVICE NOT YET RETURNED.

    Description of Event or Problem · 0

    THIS OCCURRED IN (B)(6). COMPLAINT FROM DENTAL PRACTICE: HANDPIECE 'SMOKING'. RECEPTIONIST BURNT HER FINGER ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65978 TRANSLUX® WAVE ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION EBZ HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other