BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NU SKIN GALVANIC SPA SYSTEM II

    MDR report key: 1595179 · Received February 1, 2010

    Report

    Report Number
    MW5014618
    Event Type
    Injury
    Date Received
    February 1, 2010
    Date of Event
    January 25, 2010
    Report Date
    February 1, 2010
    Manufacturer
    NU SKIN
    Product Code
    GZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHEN DOING A FACIAL TREATMENT WITH THE NU SKIN GALVANIC SPA SYSTEM II, I GOT SEVERAL BLOOD - RED PIMPLES ON MY FACE, WHICH DO NOT DISAPPEAR. I MAY NEED MEDICAL TREATMENT/INTERVENTION TO REMOVE THEM. DATES OF USE: (B) (6) 2009 -- (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NU SKIN GALVANIC SPA SYSTEM II NU SKIN GALVANIC SPA SYSTEM II GZO NU SKIN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Disability