BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARUS LUXSTAR

    MDR report key: 8081206 · Received November 16, 2018

    Report

    Report Number
    1017522-2018-00030
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    October 31, 2018
    Report Date
    November 16, 2018
    Manufacturer
    KAVO DENTAL TECHNOLOGIES, LLC
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN AUTHORIZED DISTRIBUTOR SERVICE TECHNICIAN VISUALLY INSPECTED THE MARUS UL1000 DENTAL LIGHT AT THE DOCTORS OFFICE AND DETERMINED THE LENSE HEAT SHIELD COVER HAD NOT BEEN PROPERLY RE-ATTACHED TO THE MARUS UL1000 DENTAL LIGHT DURING ROUTINE MAINTENANCE BY THE END USER. THE LENSE HEAT SHIELD COVER HAS TO BE REMOVED DURING ROUTINE MAINTENANCE WHEN REPLACING THE HALOGEN LIGHT BULB OR CLEANING THE LENS COVERS. THE USE AND CARE MANUAL IDENTIFIES HOW TO PROPERLY RE-INSTALL THE LENSE HEAT SHIELD COVER AFTER PERFORMING ROUTINE MAINTENANCE AS WELL AS LIST WARNINGS TO INSURE THE LENSE HEAT SHIELD COVER IS PROPERLY INSTALLED AFTER SERVICING. THE DISTRIBUTOR SERVICE TECHNICIAN INFORMED THE MANUFACTURER THEY PROPERLY INSTALLED THE LENSE HEAT SHIELD COVER ON THE UL 1000 DENTAL LIGHT. THIS CONCLUDES THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED A DENTIST WAS POSITIONING A MARUS UL1000 DENTAL LIGHT FOR USE WHEN THE LENSE HEAT SHIELD COVER FELL OFF THE LIGHT AND HIT THE PATIENT ON THE FOREHEAD CAUSING A BRUISE AND SWELLING. THE DENTIST GAVE THE PATIENT AN ICE PACK FOR THE SWELLING. THERE WERE NO SERIOUS INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917831 MARUS LUXSTAR DENTAL LIGHT EAZ KAVO DENTAL TECHNOLOGIES, LLC UL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR