BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEAUTY ANGEL

    MDR report key: 5335340 · Received December 29, 2015

    Report

    Report Number
    MW5058791
    Event Type
    Injury
    Date Received
    December 29, 2015
    Date of Event
    December 17, 2015
    Report Date
    December 29, 2015
    Manufacturer
    JK PRODUCTS & SERVICES, INC.
    Product Code
    LEJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT AN ADVERSE REACTION ON (B)(6) 2015, TO A DEVICE CALLED BEAUTY ANGEL. PT STATED, SHE USED THE DEVICE AT A LOCAL PLANT FITNESS, AND NOWHERE DID SHE SEE ANY WARNING THAT SAID TO WEAR EYE PROTECTION WHEN USING THE DEVICE. PT SAID ON (B)(6) 2015, SHE WAS DRIVING AND NOTICED VISION CHANGES. PT SAID ALL THE LIGHTS ON THE ROAD WERE GLARING, HER PERIPHERAL VISION WAS BLURRY, AND SHE DEVELOPED A HEADACHE. PT SAID THE CORNERS OF HER EYES FELT VERY PAINFUL, AND THAT THE SKIN AROUND HER EYES WAS SORE. ON (B)(6) 2015, THE PT SAID SHE FINALLY REALIZED HER VISION CHANGES WERE GETTING WORSE SO SHE WENT TO SEE AN EYE DOCTOR. SHE SAID THE EYE DOCTOR CONFIRMED HER VISION CHANGES, BUT COULD NOT CONFIRM IF THE DAMAGE WAS TEMPORARY OR PERMANENT. PT SAID SHE WAS REFERRED TO A RETINA SPECIALIST, BUT HAS NOT BEEN ABLE TO SCHEDULE AN APPOINTMENT YET. THE PT ALSO SAID THE SKIN ON HER FACE CHANGED, HER FRECKLES BECAME MORE NOTICEABLE, EVEN THOUGH SHE HAD PUT A T-SHIRT OVER HER FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855266 BEAUTY ANGEL BEAUTY ANGEL LEJ JK PRODUCTS & SERVICES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR