BEUDAMED
    FDA Adverse Event Summary report: N

    FRAXEL

    MDR report key: 2097154 · Received May 20, 2011

    Report

    Report Number
    1720381-2011-00027
    Date Received
    May 20, 2011
    Date of Event
    April 18, 2009
    Report Date
    May 20, 2011
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    GEX
    PMA / PMN Number
    K091420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS MADE REASONABLE ATTEMPTS BY TELEPHONE AND EMAIL TO OBTAIN FURTHER INFORMATION FROM THE INITIAL REPORTER; HOWEVER NO RESPONSE WAS RECEIVED. LUMENIS IS NOT THE MANUFACTURER OF THE FRAXEL SYSTEM, NOR DO LUMENIS DEVICES PERFORM "FRAXEL" TREATMENTS. TO THE BEST KNOWLEDGE OF LUMENIS, LUMENIS DID NOT MANUFACTURE THE DEVICE DESCRIBED IN THE VOLUNTARY MEDWATCH. NOT A LUMENIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PATIENT ON VOLUNTARY MEDWATCH (B)(4) THAT THEY WERE TREATED FOR ACNE SCARS WITH FRAXEL TREATMENT USING A "LUMINESS" LASER AND SUSTAINED "MORE SCARS AND FAT LOSS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAXEL LASER SURGICAL DELIVERY DEVICE GEX SOLTA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other