BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUXSTAR UNIT-MOUNT LIGHT

    MDR report key: 2191282 · Received July 19, 2011

    Report

    Report Number
    3004517290-2011-00008
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 22, 2011
    Manufacturer
    DENTAL EQUIPMENT LLC (DBA NEWBERG MFG)
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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. DENTAL EQUIPMENT LLC INITIATED A RECALL ON (B)(4) 2011 TO ADD A TETHER TO THE LENS HEAT SHIELD/COVER TO KEEP IT FROM FALLING OFF THE DENTAL LIGHT IF IT IS NOT RE-INSTALLED PROPERLY.

    Description of Event or Problem · 1

    A DOCTOR WAS PERFORMING ROUTINE MEDICAL TREATMENT TO A PT WHEN THE LENS HEAT SHIELD/HOLDER FROM HIS DENTAL LIGHT CAME OFF AND FELL DOWN TOWARDS THE FLOOR STRIKING THE PT IN THE FACE. THE LENS HEAT SHIELD HOLDER CAUSED A SMALL BURN TO THE PT'S FACE. NO MEDICAL TREATMENT WAS REQUIRED.

    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 MFG) UL1000

    Patients

    Seq Age Sex Outcome Treatment
    1