BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMI (GRINDGUARDN) CUSTOM NIGHT GUARD/OCCLUSAL GUARD

    MDR report key: 20558031 · Received October 28, 2024

    Report

    Report Number
    MW5161746
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    October 18, 2024
    Report Date
    October 19, 2024
    Manufacturer
    REMI
    Product Code
    OBR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I'M REACHING OUT BECAUSE I HAD A SERIOUS ISSUE WITH A MOUTHGUARD I BOUGHT THROUGH (B)(6). AFTER USING IT, I ENDED UP WITH DENTAL PROBLEMS AND AN ALLERGIC REACTION, WHICH HAD TO BE TREATED BY A TMJ SPECIALIST. I'VE ALREADY CONTACTED (B)(6) ABOUT THIS, BUT I STILL HAVEN'T BEEN GIVEN ANY REAL SOLUTION. WHAT WORRIES ME MORE IS THAT I SEARCHED THE FDA DATABASE FOR THE COMPANY THAT MAKES THIS MOUTHGUARD, AND I COULDN'T FIND IT LISTED ANYWHERE. WHEN I MENTIONED THIS TO (B)(6), THEY TOLD ME NOT TO WORRY, BUT I HONESTLY CAN'T REST EASY WITHOUT SOME CLEAR ANSWERS. COULD YOU PLEASE LOOK INTO THIS AND LET ME KNOW WHAT CAN BE DONE TO RESOLVE IT? I'D APPRECIATE IT IF YOU COULD HELP SORT THIS OUT SOON, GIVEN THE HEALTH ISSUES I'VE HAD BECAUSE OF THE PRODUCT. THIS IS THE (B)(6) MOUTHGUARD I BOUGHT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725995 REMI (GRINDGUARDN) CUSTOM NIGHT GUARD/OCCLUSAL GUARD MOUTHGUARD, OVER-THE-COUNTER OBR REMI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention