BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-SNORING MOUTHPIECE

    MDR report key: 21422274 · Received February 20, 2025

    Report

    Report Number
    MW5166547
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    February 7, 2025
    Report Date
    February 14, 2025
    Manufacturer
    QUIETLAB
    Product Code
    LRK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BELIEVE THAT THIS PRODUCT IS BEING SOLD WITHOUT CERTIFICATION AND IS NOT EFFECTIVE IN USE. I ALSO BELIEVE THAT THE PRODUCT COULD POTENTIALLY LEAD TO DAMAGING TEETH ALIGNMENT OVER TIME BASED ON MY LIMITED USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045758 ANTI-SNORING MOUTHPIECE DEVICE, ANTI-SNORING LRK QUIETLAB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male