BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMI BY GRINDGUARD, INC., CUSTOM DENTAL NIGHT GUARD

    MDR report key: 14576295 · Received June 1, 2022

    Report

    Report Number
    MW5110058
    Event Type
    Injury
    Date Received
    June 1, 2022
    Report Date
    May 28, 2022
    Manufacturer
    UNK
    Product Code
    BRW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BOUGHT THIS CUSTOM DENTAL NIGHT GUARD IN (B)(6) BECAUSE I SUFFER FROM TMJ. THEY ADVERTISE THAT THE GUARD IS THE SAME AS THE DENTIST BUT THE QUALITY WASN'T THE SAME AS THE CUSTOM NIGHT GUARD THAT MY DENTIST PRESCRIBED FOR TMJ. THE COMPANY STATES THAT THEY HAVE THE SAME QUALITY AS THE DENTIST BUT MY TMJ JUST GOT WORSE. I CAN'T HANDLE THE PAIN NOW. (B)(6); FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23708 REMI BY GRINDGUARD, INC., CUSTOM DENTAL NIGHT GUARD PROTECTOR, DENTAL BRW UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown