BEUDAMED
    FDA Adverse Event Summary report: N

    SLT II WITH CELLULAZE

    MDR report key: 3139461 · Received May 29, 2013

    Report

    Report Number
    1222993-2013-00004
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 29, 2013
    Manufacturer
    CYNOSURE, INC.
    Product Code
    OYW
    PMA / PMN Number
    K102541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ON SITE EVALUATION OF THE LASER WAS PERFORMED AND THE LASER WAS PERFORMING AS EXPECTED, NO MALFUNCTION IDENTIFIED. BLISTERS ARE KNOWN AS POSSIBLE SIDE EFFECT OF LASER PROCEDURES AND IDENTIFIED AS SUCH IN PRODUCT LABELING.

    Description of Event or Problem · 1

    PATIENT ALLEGEDLY DEVELOPED BLISTERS 2-3 DAYS POST TREATMENT. PATIENT CONDITION IS BEING TREATED WITH TOPICAL PRESCRIPTION MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234387 SLT II WITH CELLULAZE DERMATOLOGY LASER SYSTEM OYW CYNOSURE, INC. 105-0056-810

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention