BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDMARK

    MDR report key: 2070964 · Received April 20, 2011

    Report

    Report Number
    1523530-2011-00011
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 20, 2011
    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 INITIAL REPORTER BELIEVES THE LIGHT IS 4 TO 6 YEARS OLD. 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." THE FACILITY FAILED TO DO THIS WHICH LED TO THE OPERATOR BEING BURNED.

    Description of Event or Problem · 1

    WHILE REMOVING THE LIGHT SHIELD TO CLEAN, THE ASSISTANT DROPPED THE SHIELD, CATCHING IT BY THE ANALOG SHADE AND RECEIVED 2ND DEGREE BURNS ON HER HANDS. LIGHTS ARE AROUND 4 - 6 YEARS OLD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other