BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDMARK

    MDR report key: 3877795 · Received May 31, 2014

    Report

    Report Number
    1523530-2014-00010
    Event Type
    Injury
    Date Received
    May 31, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 31, 2014
    Manufacturer
    MIDMARK CORP.
    Product Code
    EAZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER OF THE LIGHT WAS NOT AVAILABLE. THE PRODUCT LITERATURE STATES "CAUTION, THE BULB MAY BE HOT! ALLOW THE BULB TO COOL FOR AT LEAST 5 MINUTES BEFORE REMOVING THE LIGHT SHIELD." ALSO NOTED IN THE INSTRUCTIONS ARE THE USE OF TWO 'RELEASE LEVERS' FOR INSTALLATION AND FOR MAINTENANCE TO ENSURE THAT THE LIGHT SHIELD IS PROPERLY FASTENED. THE FACILITY FAILED TO DO THIS WHICH LED TO THE OPERATOR BEING BURNED.

    Description of Event or Problem · 1

    WHILE POSITIONING THE LIGHT, THE LIGHT FELL OFF AND THE ASSISTANT CAUGHT THE ANALOG SHADE AND RECEIVED A BURN ON HER HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320566 MIDMARK LIGHT, OPERATING, DENTAL EAZ MIDMARK CORP. 18600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other