BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEMTRON LC

    MDR report key: 1033440 · Received April 23, 2008

    Report

    Report Number
    3003848022-2008-00001
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 25, 2008
    Manufacturer
    KERR CORPORATION
    Product Code
    EBZ
    PMA / PMN Number
    K014179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED AND FOUND TO BE WITHIN ALL SPECIFICATIONS. THE OUTER REFLECTOR WAS BROKEN INTO 3 LARGE PIECES AND THE ONLY REMAINS OF THE BULB WERE VERY TINY PIECES OF GLASS. DAMAGE TO THE HAND PIECE INDICATES SOME TYPE OF IMPACT TO THE DEVICE. LABORATORY TESTING OF THE ACTUAL DEVICE COULD NOT DUPLICATE THE ALLEGED FAILURE OF A BULB EXPLOSION. NO CONCLUSION COULD BE DRAWN. IT COULD HAVE BEEN A VERY RARE OCCURRENCE WHERE A BULB BLEW UP, OR THE HAND PIECE COULD HAVE BEEN DROPPED RESULTING IN A BROKEN REFLECTOR, BROKEN BULB, OR BOTH. NO DETERMINATION COULD BE MADE AS TO WHAT SCENARIO OCCURRED. THIS INCIDENT IS MDR REPORTABLE AS A MALFUNCTION BECAUSE IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. CONCLUSIONS: IT IS HARD TO CONCLUDE WHAT EXACTLY HAPPENED WITH THIS LC UNIT. IT COULD HAVE BEEN A RARE OCCURRENCE WHERE A BULB BLEW UP, OR THE HAND PIECE COULD HAVE BEEN DROPPED RESULTING IN A BROKEN REFLECTOR, BROKEN BULB OR BOTH. NO DETERMINATION CAN BE MADE AS TO WHAT SCENARIO OCCURRED. THE UNIT FUNCTIONS NORMAL, AND WITHIN ALL DESIGNED PARAMETERS. WHAT WAS CONCLUDED IS THAT VERY SMALL PIECES OF GLASS FROM INSIDE THE LIGHT CUP CAN FIND THEIR WAY OUTSIDE THE HOUSING IF THE HAND PIECE IS TIPPED IN THE RIGHT DIRECTION.

    Description of Event or Problem · 1

    IN 2008, A DR REPORTED TO KERR CORP THAT THE LIGHT BULB OF THE DEMTRON LC CURING LIGHT HAD EXPLODED DURING USE, AND THAT A BROKEN PIECE HAD HIT THE OPERATOR IN THE FACE. NO ONE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEMTRON LC ACTIVATOR, ULTRAVIOLET, FORPOLYMERIZATION EBZ KERR CORPORATION 61001546

    Patients

    Seq Age Sex Outcome Treatment
    1 Other