BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEMF8000

    MDR report key: 6685950 · Received July 1, 2017

    Report

    Report Number
    MW5070780
    Event Type
    Injury
    Date Received
    July 1, 2017
    Date of Event
    June 15, 2017
    Report Date
    July 1, 2017
    Manufacturer
    UNK
    Product Code
    MBQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I SELL MANY MEDICAL DEVICES ON MY WEBSITE (B)(6) AND (B)(6) CURRENTLY HAS OFFICES IN (B)(6) I PURCHASED A PEMF8000 FROM (B)(6) INCLUDING PEMF8000PRO PRODUCTS. I THOUGHT THIS UNIT WAS FDA APPROVED AND UL APPROVED BUT NOW I FIND OUT IT IS NOT! WHILE TESTING THE UNIT I GOT SUCH A SHOCK THAT SENT ME TO THE FLOOR. THIS IS A VERY DANGEROUS UNIT AND THEY ARE SELLING TO CHIROPRACTORS WHO DON'T KNOW HOW DANGEROUS IT IS. I FEEL THEIR PTS ARE IN GREAT DANGER. PLEASE LOOK INTO THIS IMMEDIATELY, AT LEAST PUT A FREEZE ON THEIR WEBSITES PENDING YOUR INVESTIGATION. I HAVE INCLUDED THEIR INFO BELOW. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463936 PEMF8000 PERIPHERALELECTROMAGNETIC FIELD MBQ UNK PEMF8000

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening