BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMI

    MDR report key: 16459603 · Received February 28, 2023

    Report

    Report Number
    MW5115307
    Event Type
    Injury
    Date Received
    February 28, 2023
    Report Date
    February 25, 2023
    Manufacturer
    REMI
    Product Code
    OBR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS IS THE THIRD TIME YOU HAVE SENT ME A NEW MOUTH GUARD THAT JUST DOESN'T FIT. THE ONE YOU JUST SENT ME IS WAY TOO THICK IN THE MOLARS AND WOULD CREATE A TMJ PROBLEM. I'M REALLY CONCERNED ABOUT YOUR QUALITY CONTROL. I CAN SEE THIS HAPPENING ONCE BUT NOT 3 TIMES. REFERENCE REPORT #MW5115308, #MW5115309.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947831 REMI MOUTHGUARD, OVER-THE-COUNTER OBR REMI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other