BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEAUTY ANGEL

    MDR report key: 5448671 · Received February 19, 2016

    Report

    Report Number
    2311923-2016-00001
    Event Type
    Injury
    Date Received
    February 19, 2016
    Date of Event
    December 17, 2015
    Report Date
    February 19, 2016
    Manufacturer
    JK PRODUCTS & SERVICES
    Product Code
    ISA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFORMATION WE HAVE, THE PATIENT HASN'T PAID ATTENTION TO THE WARNING LABELS WHICH ARE VISIBLE AT THE EYE LEVEL UPON ENTERING THE APPLIANCE (SEE ATTACHMENT JK PART NO. 1014466-00) THE LABEL STATES "PROTECTIVE EYE WEAR SUCH AS SUNGLASSES OR OTHER LIGHT REDUCING EYE WEAR IS RECOMMENDED FOR PEOPLE WHO ARE SENSITIVE TO BRIGHT LIGHT." ADDITIONALLY IN THE MANUAL THIS STATEMENT IS ALSO GIVEN REFERENCE (PAGE 22/5.3). WE HAVE VERIFIED OUR BILL OF MATERIALS INCLUDES THIS LABEL, REVIEWED OUR MANUFACTURING INSTRUCTION FOR APPLYING THIS LABEL, AND SAMPLE FINISHED GOODS TO VERIFY THE LABEL IS APPLIED AND IN THE CORRECT POSITION. WITHOUT ADDITIONAL INFORMATION AS TO THE EXACT LOCATION OF THIS APPLIANCE, WE FEEL WE HAVE PERFORMED DUE DILIGENCE IN REFERENCE TO THIS INCIDENT. IT IS OUR OPINION THE PT EITHER OVERLOOKED THE LABEL INDICATING THE USE OF EYE PROTECTION OR DISREGARDED IT ALTOGETHER. NOTE: THE STATEMENTS IN THE REPORT REFERRING TO THE BEAUTY ANGEL AS A TANNING BED ARE NOT CORRECT. THE BEAUTY ANGEL IS NOT A TANNING BED WITH CLASSIFICATION NAME: "SUN BOOTH." THERE ARE NO ULTRAVIOLET LAMPS ASSEMBLED. LOCATION OF DEVICE UNKNOWN.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FROM MEDWATCH REPORT #MW5058791.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 AND APPOINTMENT YET. THE PT ALSO SAID THE SKIN ON HER FACE CHANGED, HERE 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
    105345 BEAUTY ANGEL MASSAGER, THERAPEUTIC, ELECTRIC ISA JK PRODUCTS & SERVICES RVT30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other