BEUDAMED
    FDA Adverse Event Summary report: N

    REBUILDER 2405 SYSTEM

    MDR report key: 597108 · Received April 19, 2005

    Report

    Report Number
    MW4003924
    Date Received
    April 19, 2005
    Report Date
    April 1, 2005
    Manufacturer
    REBUILDER
    Product Code
    GZJ
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT CALLED REQUESTING VERIFICATION THAT A MEDICAL DEVICE WAS "APPROVED BY THE FDA" AS STATED IN THE FIRM'S LITERATURE PRIOR TO PURCHASING DEVICE FOR $400. COMPLAINANT WAS ELDERLY, IN POOR HEALTH AND SUFFERED SEVERELY FROM NEUROPATHY. COMPLAINANT RECEIVED ADVERTISEMENT IN THE MAIL AND ON THE INTERNET (WWW.REBUILERMEDICAL.COM) ON THE REBUILDER 2405 SYSTEM. THE REBUILDER 2405 SYSTEMS WEBSITE STATES THAT THE DEVICE IS "FDA APPROVED" AND THAT USERS ARE REBUILDING THEIR NERVES AND MUSCLES" AFTER BEING TOLD THEIR NERVES WERE DEAD. THE REBUILDER MEDICAL TECHNOLOGIES, INC. WEBSITE STATES IT IS A MEDICAL RESEARCH, DEVELOPMENT, AND MANUFACTURING COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REBUILDER 2405 SYSTEM * GZJ REBUILDER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *