BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSKIN LASER SYSTEM

    MDR report key: 3830703 · Received May 5, 2014

    Report

    Report Number
    1222993-2014-00013
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    February 27, 2014
    Report Date
    May 2, 2014
    Manufacturer
    CYNOSURE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K081424
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYNOSURE TECHNICIAN INSPECTED THE LASER SYSTEM AND FOUND NO PROBLEMS.

    Description of Event or Problem · 1

    THE PHYSICIAN TREATED THE PATIENT'S NECK AND CHEST WITH SMARTSKIN CO2 LASER SYSTEM. THE PT IS BURNED AND PRESENTED WITH KELOID SCARS AFTER THE PHYSICIAN USED INCORRECT SETTING AND OVER TREATED THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268053 SMARTSKIN LASER SYSTEM SMARTSKIN LASER SYSTEM GEX CYNOSURE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S