BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUFACE MICROCURRENT FACIAL LIFTING AND TONING DEVICES

    MDR report key: 4728007 · Received April 21, 2015

    Report

    Report Number
    MW5042237
    Event Type
    Injury
    Date Received
    April 21, 2015
    Date of Event
    April 21, 2015
    Report Date
    April 21, 2015
    Manufacturer
    CAROL COLE COMPANY
    Product Code
    NFO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS IS (B)(6), A CUSTOMER WHO PURCHASED NUFACE MICROCURRENT FACIAL LIFTING AND TONING DEVICES SEVERAL WEEKS AGO. AFTER USING THIS DEVICE THREE TIMES FOLLOWING THE USER'S INSTRUCTION, I HAVE HAD REALLY SEVERE SIDE EFFECTS: MY FACE SKIN BECAME DRY AND RED, THEN STARTED TO PEEL OFF AND LEFT DARK RED SPOT ON MY FACE. I CONTACTED CUSTOMER SERVICE FROM NUFACE AND GOT THE RESOLUTION ON REFUND THE PURCHASE. HOWEVER, THEY ARE NOT RESPONSIBLE FOR THE MEDICATION SERVICE AND SALARY LOSS FOR ME AT THIS MOMENT. AS THE NUFACE DEVICE WAS AUTHORIZED BY FDA, I WAS WONDERING WHETHER YOU COULD HELP TO REEVALUATE THIS DEVICE. I DON'T WANT TO SEE OTHER PEOPLE SUFFERING SIDE EFFECTS THAT I HAVE BEEN THROUGH. PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS OR NEED ANY INFO. I CAN SEND YOU THE PROOF OF MY PURCHASE AND THE SIDE EFFECT PICTURES (I HAVE PICTURES BEFORE AND AFTER USING THE DEVICE). THANK YOU VERY MUCH FOR YOUR TIME AND HELP. DATES OF USE: (B)(6) 2015; DIAGNOSIS OR REASON FOR USE: WANTED TO DECREASE THE WRINKLE ON THE FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263302 NUFACE MICROCURRENT FACIAL LIFTING AND TONING DEVICES FACIAL LIFE AND TONING NFO CAROL COLE COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R| S