BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMER

    MDR report key: 9641774 · Received January 28, 2020

    Report

    Report Number
    MW5092593
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    January 12, 2020
    Report Date
    January 26, 2020
    Manufacturer
    BEMER INT. AG
    Product Code
    ISA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ALLERGY AND POSSIBLE EMBOLI'S. BEMER MACHINE CAUSED ALLERGY ON MY BROTHER. ABOUT 20 YEARS AGO, I KNEW SHAKING VEIN WALLS RELEASE THE VEIN WALL ACCUMULATED TOXINS. I DID NOT KNOW I WOULD GET AN ALLERGY IF THE TOXINS WOULD BE RELEASED INTO THE BLOOD FLOW. I DID SHAKE THE VEIN WALLS IN MY HEAD BY PASSING A HAIR BRUSH MANY TIMES. I SUDDENLY GOT AN ALLERGY AND GOT SWOLLEN. I WENT TO THE EMERGENCY ROOM AND GOT ANTIHISTAMINE INJECTIONS. THE BEMER MACHINE THAT YOU APPROVED AS A CLASS 1 MEDICAL DEVICE WORKS THE SAME WAY WITH ELECTROMAGNETIC IMPULSES SHAKING THE VEIN WALLS. SO I BET THIS IS WHAT CAUSED AN ALLERGY ON MY BROTHER. THIS MACHINE CAN ALSO MAKE THE VEIN WALLS SHAKE AWAY CHOLESTEROL TRAPPED IN CALCIUM ON THE VEIN WALLS CAUSING MAJOR PROBLEMS FOR PTS. BEMERGROU.COM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103197 BEMER MASSAGER, THERAPEUTIC, ELECTRIC ISA BEMER INT. AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other