BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBUILDER

    MDR report key: 698009 · Received March 29, 2006

    Report

    Report Number
    MW1038375
    Event Type
    Injury
    Date Received
    March 29, 2006
    Date of Event
    March 29, 2006
    Report Date
    March 29, 2006
    Manufacturer
    REBUILDER MEDICAL TECHNOLOGY, INC
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT KNOWN AS "THE REBUILDER" IS ONLY FDA APPROVED FOR PAIN RELIEF. HOWEVER, IT IS BEING MARKETED TO CONSUMERS AS "APPROVED FOR NEUROPATHY." THIS IS VERY MISLEADING AND THE DEVICE CAN GET HOT OR BURN IF NOT USED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REBUILDER THE REBUILDER GZJ REBUILDER MEDICAL TECHNOLOGY, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R