BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVOS DNA

    MDR report key: 22012127 · Received May 13, 2025

    Report

    Report Number
    MW5170264
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 2, 2023
    Report Date
    May 6, 2025
    Manufacturer
    VIVOS THERAPEUTICS INC.
    Product Code
    LRK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED A VIVOS DNA APPLIANCE FROM MY DENTIST. AFTER I PICKED IT UP THAT DAY, I HEARD HIM TELL ANOTHER PATIENT "IT'S JUST A BAND-AID" AFTER I SPENT (B)(6) ON THIS. I WORE IT AND WAS TOLD IT WOULD HELP WITH CLENCHING AND AIRWAY. AFTER SEVERAL YEARS OF USE, I HAD NO PAIN RESOLUTION, ONLY MORE BITE ISSUES, AND EXPOSED GUMS THAT NOW HAVE DEEPER POCKETS THAN BEFORE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825624 VIVOS DNA DEVICE, ANTI-SNORING LRK VIVOS THERAPEUTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female