BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUXSTAR STANDARD POST-MOUNT LIGHT

    MDR report key: 10944443 · Received December 4, 2020

    Report

    Report Number
    1017522-2020-00014
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    October 28, 2020
    Report Date
    December 3, 2020
    Manufacturer
    KAVO DENTAL TECHNOLOGIES, LLC
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HEAT SHIELD/HOLDER FROM THE DENTAL LIGHT HAS A THREE PRONG LOCKING MECHANISM WHICH LOCKS THE LENS HEAT SHIELD/COVER INTO PLACE. THE LENS HEAT SHIELD/COVER HAS TO BE REMOVED BY THE END USER WHEN CLEANING THE LENS OR REPLACING THE HALOGEN BULB DURING ROUTINE OPERATOR MAINTENANCE. THE INSTALLATION INSTRUCTIONS, USE AND CARE INSTRUCTIONS, AND LABELING CLEARLY STATE TO ENSURE THE LENS HEAT SHIELD/HOLDER IS PROPERLY SECURE BY SNAPPING THE PART BACK INTO PLACE. THE LIGHT WAS MANUFACTURED IN OCTOBER 2001 AND IS OVER 19 YEARS OLD AND PAST ITS EXPECTED LIFE. THIS CONCLUDES THE INVESTIGATION.

    Description of Event or Problem · 1

    A DENTAL PROFESSIONAL WAS TREATING A PATIENT WHEN THE LENS HEAT SHIELD COVER FELL OFF A MARUS DENTAL LIGHT HITTING THE PATIENT CAUSING A SMALL BURN. THERE WERE NO SERIOUS INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412414 LUXSTAR STANDARD POST-MOUNT LIGHT DENTAL LIGHT EAZ KAVO DENTAL TECHNOLOGIES, LLC UL1000

    Patients

    Seq Age Sex Outcome Treatment
    1