BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMI MOUTH GUARD

    MDR report key: 20578283 · Received October 30, 2024

    Report

    Report Number
    MW5161959
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 24, 2024
    Manufacturer
    REMI
    Product Code
    OBR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SHORTLY AFTER BEGINNING USE OF THE REMI NIGHT GUARD, I NOTICED SIGNIFICANT DISCOMFORT IN MY JAW, WHICH PROGRESSIVELY WORSENED OVER TIME. INSTEAD OF ALLEVIATING TENSION, THE NIGHT GUARD CAUSED HEIGHTENED DISCOMFORT IN MY TEMPOROMANDIBULAR JOINT (TMJ). THE PAIN EXTENDED TO MY JAW MUSCLES AND SURROUNDING FACIAL AREA, MAKING IT DIFFICULT TO OPEN AND CLOSE MY MOUTH. PRIOR TO USING THE REMI NIGHT GUARD, I DID NOT HAVE ANY DIAGNOSED TMJ ISSUES. HOWEVER, THE PERSISTENT PAIN FROM WEARING THE GUARD LED ME TO SEEK MEDICAL ATTENTION FROM A TMJ SPECIALIST. AFTER WEARING THE MOUTH GUARD FOR 2 WEEKS, THE PAIN BECAME UNBEARABLE, FORCING ME TO CONSULT A TMJ SPECIALIST. THE SPECIALIST DIAGNOSED ME WITH AGGRAVATED TMJ DYSFUNCTION, ATTRIBUTED TO THE ILL-FITTING NIGHT GUARD. I CEASED USING THE REMI NIGHT GUARD ON THE ADVICE OF MY TMJ SPECIALIST. SINCE THEN, I HAVE BEEN UNDERGOING TREATMENT FOR TMJ, INCLUDING PHYSICAL THERAPY AND ADJUSTMENTS TO MY BITE, WHICH HAVE INCURRED SIGNIFICANT MEDICAL EXPENSES. THE PAIN CAUSED BY THE NIGHT GUARD AFFECTED MY ABILITY TO SPEAK, EAT, AND FUNCTION NORMALLY THROUGHOUT THE DAY. I HAVE INCURRED ADDITIONAL MEDICAL EXPENSES, INCLUDING SPECIALIST CONSULTATIONS, DIAGNOSTIC IMAGING, AND ONGOING THERAPY FOR TMJ RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960778 REMI MOUTH GUARD MOUTHGUARD, OVER-THE-COUNTER OBR REMI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other