BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE MD

    MDR report key: 6073636 · Received November 2, 2016

    Report

    Report Number
    1222993-2016-00053
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    October 3, 2016
    Report Date
    November 2, 2016
    Manufacturer
    CYNOSURE INC
    Product Code
    GEX
    PMA / PMN Number
    K034030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS PRESCRIBED TOPICAL HYDROCORTISONE AND 1% SILVER SULFADIAZINE AS INTERVENTION MEDICATION FOR POST CARE TREATMENT. TREATMENT SETTINGS WERE WITHIN CLINICAL GUIDELINES. DEVICE WAS EVALUATED AND FOUND TO BE OPERATING AS INTENDED. BURNS ARE AN EXPECTED SIDE EFFECT FROM LASER TREATMENTS, BUT REPORTABLE IN THIS INCIDENT SINCE THE PATIENT HAD MEDICATION FOR INTERVENTION USE.

    Description of Event or Problem · 1

    PATIENT DEVELOPED PINPOINT BURNS FROM A LASER TREATMENT ON THE UNDER-ARM AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723898 ELITE MD ELITE MD GEX CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other