BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLEY

    MDR report key: 4704248 · Received April 17, 2015

    Report

    Report Number
    2428235-2015-00002
    Event Type
    Injury
    Date Received
    April 17, 2015
    Date of Event
    March 11, 2015
    Report Date
    April 2, 2015
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    GEX
    PMA / PMN Number
    K123777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED A SERIES OF TATTOO REMOVAL TREATMENTS WITH THE MEDLEY LASER. DURING THE FOURTH TREATMENT, THE USER MADE TWO PASSES AT THE MAXIMUM POWER SETTING. A BURN IN THE TREATMENT AREA RESULTED. THE LASER WAS EVALUATED AND FOUND TO BE FUNCTIONING WITHIN SPECIFICATIONS AND FREE OF ANY DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256994 MEDLEY MULTILASER SYSTEM GEX CYNOSURE, INC. DBA ELLMAN SSMED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention