BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELLEVE S5

    MDR report key: 5563745 · Received April 8, 2016

    Report

    Report Number
    2428235-2016-00005
    Event Type
    Injury
    Date Received
    April 8, 2016
    Date of Event
    March 8, 2016
    Report Date
    April 8, 2016
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    GEI
    PMA / PMN Number
    K123366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT EVALUATED AS CUSTOMER DID NOT RETURN UNIT BECAUSE CUSTOMER AGREED THAT THE RESULTING BURN WAS DUE TO USE OF OIL INSTEAD OF GEL. MANUFACTURER INSTRUCTIONS RECOMMEND USE OF GEL.

    Description of Event or Problem · 1

    PATIENT UNDERWENT TREATMENT FOR WRINKLE REDUCTION AND SUFFERED AN EPIDERMAL SKIN BURN TO THE FOREHEAD. OPERATOR INDICATED OIL WAS USED INSTEAD OF THE RECOMMENDED GEL, AND RESULTED IN BURNS BETWEEN EYEBROWS, SKIN, AND FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217413 PELLEVE S5 PELLEVE S5 GEI CYNOSURE, INC. DBA ELLMAN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other