BEUDAMED
    FDA Adverse Event Other Summary report: N

    KNIGHT MODEL L

    MDR report key: 1893079 · Received October 29, 2010

    Report

    Report Number
    MW5018044
    Event Type
    Other
    Date Received
    October 29, 2010
    Date of Event
    October 20, 2010
    Manufacturer
    MIDMARK
    Product Code
    EAZ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INCIDENT DESCRIPTION = LAMP SHIELD FROM OPERATORY LIGHT FELL ON PATIENT'S FACE WHILE IN DENTAL CHAIR RECEIVING DENTAL EXAM/PROPHY. PATIENT RECEIVED MINOR BURNS TO FACE FROM HOT LAMP SHIELD. INCIDENT HAPPENED TOWARD END OF APPOINTMENT DURING WHICH TIME THE OPERATORY LIGHT HAD BEEN IN USE. LAMP SHIELD SEEMED TO HAVE SPONTANEOUSLY RELEASED FROM LIGHT WITHOUT PROVOCATION/MANIPULATION. LAMP IN OPERATORY LIGHT GENERATES HIGH TEMPERATURES. I BELIEVE THIS MODEL OF LIGHT IS NO LONGER MANUFACTURED. IT IS UNCERTAIN WHETHER LAMP SHIELD CAME LOOSE ON ITS OWN OR DUE TO OPERATOR ERROR (IMPORTER TIGHTENING), BUT LIGHT HAD BEEN IN USE FOR NEARLY A WEEK WITHOUT INCIDENT SINCE IT HAD LAST BEEN CLEANED AND SHIELD REMOVED AND ADJUSTED FOR CLEANING. EXTREME HEAT FROM BULB DOES AFFECT MELTING ON ANOTHER LIGHT COMPONENT, THE REFLECTOR COVER. FOLLOW-UP CALL WITH MOM (B)(6) 2010 APPROX 24 HRS LATER - MOM REPORTS BLISTERING ON FACE AND REDNESS HAVE ALL RESOLVED AND PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIGHT MODEL L DENTAL OPERATING LIGHT EAZ MIDMARK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR