BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORAL-B NIGHTTIME DENTAL GUARD

    MDR report key: 14495058 · Received May 24, 2022

    Report

    Report Number
    MW5109899
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    January 1, 2022
    Report Date
    May 22, 2022
    Manufacturer
    ORALABS, INC.
    Product Code
    OBR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED AN ORAL B NIGHTTIME MOUTH GUARD (B)(6) FOR FIVE MONTHS. IT DEFORMED MY MOUTH (MY DENTIST WROTE "OPEN BITE DEVELOPING POSTERIORLY") AND NOW I MIGHT HAVE TO PAY (B)(4) AND WEAR BRACES FOR 18 MONTHS TO FIX IT. THIS PRODUCT SHOULD NOT BE ALLOWED ON THE MARKET. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193856 ORAL-B NIGHTTIME DENTAL GUARD MOUTHGUARD, OVER-THE-COUNTER OBR ORALABS, INC. I00028074

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Disability| R