BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUXSTAR DENTAL LIGHT

    MDR report key: 1739024 · Received June 25, 2010

    Report

    Report Number
    3004517290-2010-00003
    Event Type
    Injury
    Date Received
    June 25, 2010
    Date of Event
    November 13, 2009
    Report Date
    May 28, 2010
    Manufacturer
    DENTAL EQUIPMENT LLC (DBA NEWBERG MFG)
    Product Code
    EAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OVER THE PAST MONTH SINCE WE BECAME AWARE OF THIS INCIDENT, WE HAVE BEEN REQUESTING MORE INFO FROM OUR DISTRIBUTOR REGARDING THIS EVENT; HOWEVER, WE ARE STILL MISSING SOME OF THE INFO AS NOTED ABOVE AS THE DISTRIBUTOR WAS GOING OFF MEMORY (THE DATE OF THE EVENT IN (B) (6) 2009). THE LENS HEAT SHIELD/HOLDER FROM THE DENTAL LIGHT HAS 3 METAL TABS 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. 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 ALLEGEDLY THE LENS HEAT SHIELD /HOLDER FELL OFF THE LIGHT AND HIT THE PT ON THE FACE WHICH ALLEGEDLY CAUSED A BURN TO THE PATIENT'S FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUXSTAR DENTAL LIGHT DENTAL OPERATING LIGHT EAZ DENTAL EQUIPMENT LLC (DBA NEWBERG MFG) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1