BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBUILDER

    MDR report key: 1071090 · Received July 8, 2008

    Report

    Report Number
    MW5007544
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    May 10, 2008
    Report Date
    July 8, 2008
    Manufacturer
    REBUILDER MEDICAL TECHNOLOGY INC
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER REPORTS THAT AFTER SHE USED THE REBUILDER SHE STARTED TO EXPERIENCE PAIN, MUSCLE SPASMS, SLEEP DISTURBANCE, SWOLLEN GLANDS, HEADACHES, NERVE DAMAGE, BLURRING OF VISION, PROBLEMS WITH WALKING AND FATIGUE. REPORTER STATES THAT SHE WAS NOT MADE AWARE OF THESE SIDE EFFECTS WHEN USING THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REBUILDER NONE GZJ REBUILDER MEDICAL TECHNOLOGY INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR