BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOPREMI NIGHT GUARD

    MDR report key: 18094214 · Received November 7, 2023

    Report

    Report Number
    MW5147916
    Event Type
    Injury
    Date Received
    November 7, 2023
    Report Date
    November 2, 2023
    Manufacturer
    REMI
    Product Code
    OBR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BOUGHT A CUSTOM NIGHT GUARD FROM SHOPREMI - DID NOT FIT BUT WASN'T TOLD HOW TO FIX. PREDATORY SUBSCRIPTION BUSINESS MODEL, DIDN'T EVEN GET MY GUARD 2 MONTHS AFTER ORDER. GUARD WAS THE WRONG TYPE FOR MY ISSUE. DIDN'T FIT, CAUSED WORSE TMJ PROBLEMS. MY TMJ DOCTOR TOLD ME THEY DIDN'T FIT IT WELL EITHER CAUSING WORSE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804369 SHOPREMI NIGHT GUARD MOUTHGUARD, OVER-THE-COUNTER OBR REMI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Required Intervention