BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NTI TENSION SUPPRESSION SYSTEM

    MDR report key: 1623652 · Received March 2, 2010

    Report

    Report Number
    MW5015011
    Event Type
    Injury
    Date Received
    March 2, 2010
    Date of Event
    February 6, 2010
    Report Date
    March 2, 2010
    Manufacturer
    NTI
    Product Code
    LQZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRESCRIBED THE NTI-TSS DEVICE AND IS EXPERIENCING SEVERE DIZZINESS, EAR PAIN AND SWELLING, AND VISION ISSUES. IT IS DIFFICULT TO GO ABOUT DAILY ACTIVITIES WITH THESE SYMPTOMS. TEETH ON LEFT SIDE OF MOUTH TOUCH WHILE TEETH ON RIGHT ARE NOT. DENTISTS AND ENT DOCTORS DON'T KNOW WHAT TO DO AND ARE UNABLE TO HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NTI TENSION SUPPRESSION SYSTEM NTI-TSS LQZ NTI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention