BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUXSTAR STANDARD UNIT MOUNT LIGHT

    MDR report key: 1230220 · Received November 13, 2008

    Report

    Report Number
    3004517290-2008-00003
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 28, 2008
    Manufacturer
    DENTAL EQUIPMENT, LLC (DBA NEWBERG MANUFACTURING)
    Product Code
    EAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DENTAL LIGHT WAS EVALUATED IN 2008, AND THERE WERE NO DEFECTIVE COMPONENTS IDENTIFIED DURING THE INSPECTION. THERE WERE TWO SCREWS THAT WERE SLIGHTLY LOOSE, AND ONE SCREW THAT WAS SEVERELY LOOSE. IT WAS EVIDENT THAT SOMEONE HAS BEEN SERVICING THIS LIGHT SOMETIME IN THE PAST, DUE TO THE WRENCH MARKS ON THE THREE HEX SCREW HEADS. HOWEVER, EVEN WITH THE LOOSE SCREWS THE LENS HEAT SHIELD/HOLDER STILL SNAPPED SECURELY INTO PLACE. THE LIGHT SHIELD LOOKED LIKE IT WAS AN AFTER MARKET SHIELD; THEREFORE, THE LENS HEAT SHIELD/HOLDER HAD BEEN REMOVED SOMETIME IN THE PAST. THE LENS HEAT SHIELD/HOLDER ALSO HAS TO BE REMOVED, WHEN REPLACING THE HALOGEN LIGHT BULB OR WHEN CLEANING THE LENS COVERS. THE LENS HEAT SHIELD/HOLDER SNAPS OF THEN SNAPS BACK ON WHEN SERVICING IS COMPLETE. 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. OUR INVESTIGATION CONCLUDES THE LIGHT DOES WORK ACCORDING TO MANUFACTURER'S SPECIFICATIONS, AND WAS NOT PROPERLY SERVICED IN THE PAST BY NOT SNAPPING THE LENS HEAT SHIELD/HOLDER BACK INTO PLACE ON THE LIGHT HEAD ASSEMBLY.

    Description of Event or Problem · 1

    A DOCTOR WAS USING A DENTAL LIGHT DURING PATIENT TREATMENT, WHEN THE LENS HEAT SHIELD/HOLDER FELL FROM THE LIGHT ONTO THE PATIENT'S CHIN, CAUSING A BLISTER/BURN TO THE PATIENT'S CHIN. THE LENS HEAT SHIELD/HOLDER WEIGHS LESS THAN 1 POUND; HOWEVER, IT CAN GET HOT, DUE TO BEING CLOSE TO THE HALOGEN LIGHT BULB ASSEMBLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention