BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIGHT GUARD

    MDR report key: 15543380 · Received October 4, 2022

    Report

    Report Number
    MW5112425
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    September 15, 2022
    Report Date
    September 30, 2022
    Manufacturer
    REMI
    Product Code
    OBR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A NIGHT GUARD ONLINE AND AFTER I GOT IT IN THE MAIL AND WORE IT, I WOKE UP THE NEXT DAY WITH MY TEETH FEELING LIKE THEY WERE MOVED AND WERE HURTING. I WORE IT AGAIN THE NEXT NIGHT BUT I CAN TELL IT WAS MOVING MY TEETH AND MY GUMS WERE BLEEDING. I KNEW THIS WAS NOT RIGHT SO I CONTACTED MY DENTIST WHO WAS ABLE TO SEE ME RIGHT AWAY AND LOOK AT MY GUARD FROM REMI. SHE TOLD ME THAT IT WAS DEFINITELY CAUSING AN ALIGNMENT ISSUE. IT WAS CAUSING A MALOCCLUSION AND SUGGESTED A DIFFERENT SOLUTION OTHER THAN THIS COMPANY. SHE SAID THE QUALITY OF THIS PRODUCT WAS NOT GOOD AND NOW I HAVE TO PAY FOR AN EXPENSIVE TREATMENT. STAY AWAY FROM THIS COMPANY BECAUSE THEY DO NOT ANSWER CUSTOMER SERVICE REQUESTS AND NOW I HAVE TO PAY A TON OF MONEY FOR WHAT? FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311576 NIGHT GUARD MOUTHGUARD, OVER-THE-COUNTER OBR REMI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention