BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICON

    MDR report key: 3934273 · Received June 27, 2014

    Report

    Report Number
    1222993-2014-00020
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 26, 2014
    Product Code
    GEX
    PMA / PMN Number
    K110907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    PATIENT RECEIVED HAIR REMOVAL TREATMENT ON HER LEGS AND PRESENTED WITH BURNS. THE PATIENT HAD RECENT SUN EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377949 ICON ICON GEX

    Patients

    Seq Age Sex Outcome Treatment
    1