BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUXSTAR CEILING-MOUNT LIGHT

    MDR report key: 1679461 · Received May 6, 2010

    Report

    Report Number
    3004517290-2010-00001
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 7, 2010
    Manufacturer
    DENTAL EQUIPMENT, LLC (DBA NEWBERG MANUFACTURING)
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE LENS HEAT SHIELD/HOLDER FROM THE DENTAL LIGHT HAD ITS 3 METAL TABS BENT WHICH LOCKS THE LENS HEAT SHIELD/COVER INTO PLACE. AS A RESULT, THE LENS HEAT SHIELD/COVER WOULD NOT BE ABLE TO BE RE-INSTALLED PROPERLY DURING ROUTINE MAINTENANCE OF THE DENTAL LIGHT. THE LENS HEAT SHIELD/COVER HAS TO BE REMOVED BY THE END USER WHEN CLEANING THE LENS OR REPLACING THE HALOGEN BULB. THE DR INFORMED US THAT HE HAD BEEN INFORMED TO BEND THESE TABS IN THE PAST BY HIS INDEPENDENT SERVICE PROVIDER DURING HIS ROUTINE MAINTENANCE OF THE LIGHT ASSEMBLY. 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.

    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 HIT THE PT ON THE FACIAL AREA CAUSING THE PT'S LIP TO SWELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUXSTAR CEILING-MOUNT LIGHT DENTAL OPERATING LIGHT EAZ DENTAL EQUIPMENT, LLC (DBA NEWBERG MANUFACTURING) CL1000

    Patients

    Seq Age Sex Outcome Treatment
    1