BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICON

    MDR report key: 6064220 · Received October 28, 2016

    Report

    Report Number
    1222993-2016-00051
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 2, 2016
    Report Date
    October 28, 2016
    Manufacturer
    CYNOSURE INC
    Product Code
    GEX
    PMA / PMN Number
    K142376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER EXPERIENCED HYPERPIGMENTATION ON THEIR FACE AFTER A LASER TREATMENT. THE TREATMENT PARAMETERS WERE NOT WITHIN SPECIFICATIONS. THE PHYSICIAN STATED THAT HE MISJUDGED THE PATIENT'S SKIN TYPE AND USED PARAMETERS THAT WERE TOO HIGH. HIGH PARAMETERS CAN CAUSE HYPERPIGMENTATION. THERE IS NO LONG TERM INJURY ANTICIPATED. THIS IS REPORTABLE BECAUSE THE PATIENT WAS PRESCRIBED MEDICATION FOR INTERVENTION PURPOSES. CUSTOMER DECLINED SERVICE FOR DEVICE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HYPERPIGMENTATION ON THEIR FACE AFTER A LASER TREATMENT. THE PATIENT RECEIVED MEDICINE FOR INTERVENTION PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714704 ICON ICON GEX CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other