BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUXSTAR POST MOUNT LIGHT

    MDR report key: 2445299 · Received January 28, 2012

    Report

    Report Number
    3004517290-2012-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2012
    Date of Event
    December 12, 2011
    Report Date
    January 6, 2012
    Manufacturer
    DENTAL EQUIPMENT LLC (DBA NEWBERG MANUFACTURING
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    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 JUNE 10, 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. PLEASE REFERENCE FDA RECALL NUMBER Z-2834-2011.

    Description of Event or Problem · 1

    A DOCTOR WAS PERFORMING ROUTINE MEDICAL TREATMENT TO A PATIENT WHEN THE LENS HEAT SHIELD/HOLDER FROM HIS DENTAL LIGHT CAME OFF THE LIGHT AND FELL ON THE PATIENT NECK CAUSING A BURN AND BLISTER TO THE PATIENTS NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUXSTAR POST MOUNT LIGHT DENTAL OPERATING LIGHT EAZ DENTAL EQUIPMENT LLC (DBA NEWBERG MANUFACTURING UL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR