BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM NIGHT GUARD FOR BRUXISM/TMJ

    MDR report key: 19269303 · Received May 7, 2024

    Report

    Report Number
    MW5154651
    Event Type
    Injury
    Date Received
    May 7, 2024
    Report Date
    May 4, 2024
    Manufacturer
    REMI
    Product Code
    OBR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BOUGHT A CUSTOM NIGHT GUARD FROM REMI BUT MY TMJ/BRUXISM GOT WORSE AND HAD TO GO TO THE DENTIST TO GET THE PROBLEM SOLVED. I NOTICED THEY ARE NOT EVEN REGISTERED IN THE FDA WEBSITE AFTER THE DENTIST TOLD ME I SHOULDN'T BUY FROM THEM. HTTPS://WWW.AMAZON.COM/REMI-AT-HOME-CUSTOM-NIGHT-GUARD/DP/B0899M1B2W/REF=SR_1_3_PP?CRID=2P49NNKHE2I5G&DIB=EYJ2IJOIMSJ9.C_Z-03BNQDGDEHOOTW_MPPRYKE9ZQWDYOF5GEUSLPGT7NJOL782BL7LMVHMZR5XLWYTLX5HQDO9BPJRH_HOVLNLYIWIJ3ZLMXWXAPFEMBN4QGKHHOFA26NQEVVBZPGL6LPVPS2P1HTTNCJUA61Z7-OOKPG1306YTS9OQ_YOBMG-5TTC0B2PUESBBOHUNCQI8G4BUPUTERIAZFBRP3UYJP4PDOQTRMVNLF7BKD8MIW8WCIVQNGRNC1FVBPCA-JCDUB0DWJPRMAB2LOYXESW1U3UB6J-TV8J_FCNMUBN73-FO.7332U7EVLR_5LGMN67NXLF-4V_AI0YKOJ7L17IAOWI8&DIB_TAG=SE&KEYWORDS=REMI+GUARD&QID=1714865367&SPREFIX=REMI+GUAR%2CAPS%2C136&SR=8-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477996 CUSTOM NIGHT GUARD FOR BRUXISM/TMJ MOUTHGUARD, OVER-THE-COUNTER OBR REMI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention