BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUXSTAR UNIT-MOUNT LIGHT

    MDR report key: 1920104 · Received December 7, 2010

    Report

    Report Number
    3004517290-2010-00006
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    October 26, 2007
    Report Date
    November 8, 2010
    Manufacturer
    DENTAL EQUIPMENT LLC (DBA NEWBERG MANUFACTURING)
    Product Code
    EAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS/CONCLUSIONS: 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 MAINTENANCE. THE INVESTIGATION OF THE LENS HEAT SHIELD/HOLDER IDENTIFIED NO PROBLEMS WITH THE RETURNED PART. OUR CONCLUSION IS THE LENS HEAT SHIELD/COVER WAS NOT REINSTALLED CORRECTLY DURING ROUTINE MAINTENANCE BECAUSE IF IT WAS REINSTALLED AND LOCKED INTO PLACE THE PART WOULD NOT HAVE FALLEN OFF THE LIGHT. 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. NOTE - THIS EVENT TOOK PLACE THREE (3) YEARS AGO. WE BECAME AWARE OF THIS EVENT DURING OUR EVALUATION OF MANUFACTURE REPORT # 3004517290-2010-00005.

    Description of Event or Problem · 1

    A DOCTOR WAS PERFORMING A ROUTINE DENTAL PROCEDURE WHEN THE LENS HEAT SHIELD/HOLDER FELL OFF THE LIGHT AND BURNED AND SCRAPED THE PATIENT ON THE CHIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUXSTAR UNIT-MOUNT LIGHT DENTAL OPERATING LIGHT EAZ DENTAL EQUIPMENT LLC (DBA NEWBERG MANUFACTURING) OL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention