BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PMD PERSONAL MICRODERM

    MDR report key: 5187619 · Received October 23, 2015

    Report

    Report Number
    MW5057540
    Event Type
    Injury
    Date Received
    October 23, 2015
    Date of Event
    October 20, 2015
    Report Date
    October 23, 2015
    Manufacturer
    AGE SCIENCES INC.
    Product Code
    GFE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A PMD MICRODERMABRASION DEVICE. I STRICTLY FOLLOWED THE INSTRUCTIONS. I EXPERIENCED A SLIGHT SENSATION WHILE USING THE DEVICE AS THE INSTRUCTION MANUAL STATED I WOULD. UPON COMPLETION OF THE TREATMENT MY SKIN HAD A REDDISH COLOR WITH SLIGHT BURNING SENSATION. AS THE DAY PROGRESSED THE BURNING SENSATION INCREASED AND SWELLING APPEARED. THE BURNING SENSATION REQUIRED PAIN MEDICATION AS WELL AS ICING OF THE SKIN. I WAS UNABLE TO GO TO WORK FOR 2 DAYS. THIS DEVICE IS DANGEROUS FOR AT HOME AND USE AND SHOULD NOT BE USED BY NON-PROFESSIONALS. THERE IS NO WARNING IN THE INSTRUCTIONS THAT THIS TYPE OF INJURY COULD OCCUR. THREE DAYS AFTER THE HOME TREATMENT, MY SKIN IS SCABBED AND POSSIBLY SCARRED, I AM MONITORING FOR INFECTION. I CONTACTED THE COMPANY, AND THE MANAGER I SPOKE WITH INDICATED THAT HIS GIRLFRIEND HAD THE SAME PROBLEM. THEY ARE AWARE OF THIS PROBLEM, YET THEY CHOSE NOT TO ALERT CONSUMERS TO THE POSSIBILITY OF SERIOUS INJURY. THE COMPANY REPRESENTATIVE WAS SUPPOSED TO CALL ME BACK TO DAY, BUT FAILED TO DO SO, WHEN I CALLED THEIR OFFICES, NO ONE WAS THERE. I'M NOT SURE IF THIS IS A FLY BY NIGHT COMPANY, BUT THEY ARE UNWILLING TO STAND BEHIND THEIR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702278 PMD PERSONAL MICRODERM PMD PERSONAL MICRODERM GFE AGE SCIENCES INC. NONE LISTED NONE LISTED

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention