BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLY

    MDR report key: 4189076 · Received October 17, 2014

    Report

    Report Number
    2428235-2014-00005
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    July 22, 2014
    Report Date
    October 15, 2014
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    GEX
    PMA / PMN Number
    K123777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED AN ER; YAG TREATMENT ON THE FACE PRIOR TO THE PHYSICIAN BEING TRAINED IN THE PROPER USE OF THE DEVICE. THE PHYSICIAN USED SETTINGS THAT WERE TOO HIGH. THIS RESULTED IN MINOR BURNS AND HYPERPIGMENTATION IN THE TREATMENT AREAS. THE HYPERPIGMENTATION MAY RESOLVE OVER TIME WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662062 MEDLY GEX CYNOSURE, INC. DBA ELLMAN SSMED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention