BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPITOUCH ALEXANDRITE LASER

    MDR report key: 555276 · Received September 24, 2004

    Report

    Report Number
    MW1033551
    Event Type
    Other
    Date Received
    September 24, 2004
    Report Date
    September 24, 2004
    Manufacturer
    SHARPLAN LASERS INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER HAVING BEEN TOLD BY A DERMATOLOGIST THAT RPTR WAS A GOOD CANDIATE, RPTR BEGAN LASER HAIR TREATMENT ON THEIR FACE USING EPITOUCH ALEXANDRITE LASER, HOWEVER, THIS RESULTED IN A SIGNIFICANT INCREASE IN HAIR GROWTH. AT NO TIME WAS THERE A DECREASE IN HAIR GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPITOUCH ALEXANDRITE LASER SUPPOSED LASER HAIR REMOVAL GEX SHARPLAN LASERS INC. 510K #K973354 *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other