BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL RE:PAIR LASER SYSTEM

    MDR report key: 1370589 · Received April 29, 2009

    Report

    Report Number
    2950711-2008-00001
    Event Type
    Injury
    Date Received
    April 29, 2009
    Date of Event
    May 9, 2008
    Report Date
    November 6, 2008
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Product Code
    GEX
    PMA / PMN Number
    K063038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HEALED WITHOUT DERMAL SCARRING OR HYPOPIGMENTATION, BUT STILL HAS TEXTURAL IRREGULARITIES ON BOTH CHEEKS. NO DEVICE MALFUNCTION WAS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED DELAYED WOUND HEALING AND HYPERKERATOSIS FOLLOWING A SINGLE TREATMENT WITH THE FRAXEL RE:PAIR LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAXEL RE:PAIR LASER SYSTEM NONE GEX RELIANT TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention V-BEAM PDL| IMIQUIMOD| PREDNISONE