BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NTI-TSS

    MDR report key: 557167 · Received October 1, 2004

    Report

    Report Number
    MW1033575
    Event Type
    Injury
    Date Received
    October 1, 2004
    Report Date
    October 1, 2004
    Manufacturer
    NTI-TSS
    Product Code
    LQZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE NTI-TSS IS A DEVICE INTENDED TO PREVENT BRUXISM -GRINDING OF TEETH- AND CLENCHING. IT IS INTENDED TO BE WORN PRIMARILY AT NIGHT. PT'S DENTIST FABRICATED ONE OF THESE DEVICES. UPON EXPRESSION OF CONCERN TO HIM, HE KINDLY REFUNDED THE ENTIRE COST OF THE DEVICE. PT'S CONCERN IS THAT THIS DEVICE POSES A SIGNFICANT THREAT OF DEATH BY CHOKING. THE NTI-TSS MEASURES NO MORE THAT 3/4" -.75 INCHES- IN ANY DIMENSION. THE CONSUMER PRODUCTS SAFETY COMMISSION GUIDELINE FOR A CHOKING HAZARD IS AN OBJECT UNDER 1.75 INCHES IN DIAMETER. THE NTI-TSS IS LESS THAN HALF THIS WIDE. ALTHOUGH THE MFR CLAIMS THAT THERE WERE NO INCIDENTS OF THE DEVICES BEING DISLODGED, IN FACT THIS COULD EASILY HAPPEN. A USER COULD DISLODGE THE NTI-TSS WITH THE TONGUE, OR, DURING SLEEP, UNCONSCIOUSLY REACH INTO THE MOUTH TO LOOSEN OR READJUST IT -IT IS VERY UNCOMFORTABLE-. IF IT REMAINED IN THE MOUTH IT COULD EASILY BECOME LODGED IN THE THROAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NTI-TSS TENSION SUPPRESSION SYSTEM FOR BRUXISM LQZ NTI-TSS * ITEM IS CUSTOM MFRD

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening