BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMNOMED

    MDR report key: 11706198 · Received April 21, 2021

    Report

    Report Number
    MW5100932
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    February 10, 2020
    Report Date
    April 20, 2021
    Manufacturer
    DENTAL PROSTHETIC SERVICES, INC./ SOMNOMED INC.
    Product Code
    LRK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A TRIAL OF SOMNOMED ORAL APPLIANCE FOR SLEEP APNEA. I DEVELOPED JAW PAIN. THE DENTIST SUGGESTED I HAVE TMJ. I WAS RECOMMENDED BY BOTH DENTIST AND SLEEP DOCTOR TO STOP USING THE DEVICE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602181 SOMNOMED DEVICE, ANTI-SNORING LRK DENTAL PROSTHETIC SERVICES, INC./ SOMNOMED INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention| S