BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE MD

    MDR report key: 3599692 · Received December 5, 2013

    Report

    Report Number
    1222993-2013-00016
    Event Type
    Malfunction
    Date Received
    December 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    CYNOSURE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K034030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CAME IN FOR HER THIRD TREATMENT AND IT IS UNKNOWN IF SHE HAD ANY EXPOSURE TO SUN. THE PATIENT CAME IN WITH BROWN HALF-MOON SHAPED MARKS ON HER CHIN AND WAS NOT GIVEN ANY MEDICATION FOR TREATMENT.

    Description of Event or Problem · 1

    SECOND PATIENT REPORT FROM THE SAME FACILITY USING THE SAME DEVICE (1222993-2013-00015): PATIENT HAD BROWN HALF-MOON SHAPED MARKS ON CHIN DAY AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632312 ELITE MD ELITE MD GEX CYNOSURE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1