BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMI NIGHT GUARD

    MDR report key: 25150075 · Received May 12, 2026

    Report

    Report Number
    MW5188036
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    March 12, 2026
    Report Date
    May 7, 2026
    Manufacturer
    GRINDGUARD INC
    Product Code
    OBR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BOUGHT 2 REMI BRAND NIGHT GUARDS IN EARLY 2026. AFTER A COUPLE OF MONTHS USE, I REALIZED IT HAD A STRONG CHEMICAL SMELL WHICH IS MORE OBVIOUS IF THE NIGHT GUARD IS SOAKED IN TAP WATER FOR ABOUT AN HOUR. IT MADE THE WATER SMELL LIKE CHEMICAL MATERIAL. I EVENTUALLY REALIZED THAT IT WAS NOT THE WATER OR THE GLASS CONTAINER, IT WAS THE NIGHT GUARD ITSELF. IF I PUT VERY CLOSE THE NOSE, I CAN SMELL THE UNPLEASANT ODOR. I STOPPED USING IT IMMEDIATELY BELIEVING IT UNSAFE AND TOXIC. THIS COMPANY SHOULD BE HELD RESPONSIBLE AND BE STOPPED. REASON FOR USE: NEED RETAINER AND NIGHT GUARD. PT: 4582. DEVICE: 1425. REF: MW5188035.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611175 REMI NIGHT GUARD MOUTHGUARD, OVER-THE-COUNTER OBR GRINDGUARD INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female MULTIVITAMIN