BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSLUX WAVE

    MDR report key: 6381112 · Received March 6, 2017

    Report

    Report Number
    3005665377-2017-00001
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    February 15, 2017
    Report Date
    February 15, 2017
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EBZ
    PMA / PMN Number
    K042199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION NUMBER 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 ARE REPORTING 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 MALFUNCTION HAS NOT BEEN DETERMINED. THIS IS CLASSIFIED AS A NEAR INCIDENT IN THAT THE TIMELY INTERVENTION OF THE STAFF PREVENTED ANY SERIOUS IMPAIRMENT TO HER HAND. DEVICE NOT YET EVALUATED.

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION NUMBER 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 ARE REPORTING 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 MALFUNCTION HAS NOT BEEN DETERMINED. THIS IS CLASSIFIED AS A NEAR INCIDENT IN THAT THE TIMELY INTERVENTION OF THE STAFF PREVENTED ANY SERIOUS IMPAIRMENT TO HER HAND. ON 3/21/2017 ADDENDUM/CORRECTION. UPON RETURN OF THE TRANSLUX POWER BLUE CURING LIGHT IN QUESTION, AND THOROUGH TESTING, THE LIGHT IS IN EXCELLENT CONDITION AND NO DEFECT WAS DETECTABLE. THIS IS A PERCEPTION ISSUE AND WOULD NOT BE POSSIBLE TO CAUSE ANY SKIN IRRITATION.

    Description of Event or Problem · 0

    THIS OCCURRED IN (B)(6). PATIENT COMPLAINED THAT CURING LIGHT WAS HOT FOR ANTERIOR RESTORATIONS. TESTED BY STAFF AND LEFT BURN MARK ON HAND.

    Description of Event or Problem · 0

    THIS OCCURRED IN (B)(6). PATIENT COMPLAINED THAT CURING LIGHT WAS HOT FOR ANTERIOR RESTORATIONS. TESTED BY STAFF AND LEFT BURN MARK ON HAND. ON 3/21/2017 ADDENDUM/CORRECTION. UPON RETURN OF THE TRANSLUX POWER BLUE CURING LIGHT IN QUESTION, AND THOROUGH TESTING, THE LIGHT IS IN EXCELLENT CONDITION AND NO DEFECT WAS DETECTABLE. THIS IS A PERCEPTION ISSUE AND WOULD NOT BE POSSIBLE TO CAUSE ANY SKIN IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162753 TRANSLUX WAVE ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION EBZ HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other