BEUDAMED
    FDA Adverse Event Other Summary report: N

    AB ENERGIZER SYSTEM

    MDR report key: 375889 · Received January 28, 2002

    Report

    Report Number
    MW1023986
    Event Type
    Other
    Date Received
    January 28, 2002
    Date of Event
    January 24, 2002
    Report Date
    January 28, 2002
    Manufacturer
    MFD FOR ELECTRONIC PRODUCTS DISTRIBUTION, LLC
    Product Code
    IPF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE BELT IS PART OF A "SYSTEM" THAT INCLUDES A DIETARY SUPPLEMENT AND A "TIGHTENING GEL". THE BELT CAN BE STRAPPED AROUND DIFFERENT BODY AREAS TO PROVIDE ELECTRICAL MUSLCE STIMULATION (EMS). THE BELT HAS 4 AREAS WHERE A MOTOR CAN BE ATTACHED. THE RPTR WAS USING IT WITH ONE OF THE SIDE SETTINGS AND APPLIED IT TO WORK ON RIGHT SIDE. IT WAS WORKING FOR A WHILE, BUT THEN IT SHUT OFF. EVENTUALLY, RPTR RECEIVED A SHOCK TO RIGHT SIDE AFTER PUSHING THE OPERATING BUTTONS. IT BROKE THE SKIN, CAUSING BLEEDING AND PAIN. RPTR DID NOT SEEK MEDICAL ATTENTION. IT IS HEALING. THEY ALSO REPORT THE BELT LEAVES MARKS ON THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AB ENERGIZER SYSTEM "ELECTRONIC EXERCISING BELT" IPF MFD FOR ELECTRONIC PRODUCTS DISTRIBUTION, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other