BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNOREMD MICRO-ADJUSTABLE SNORING MOUTHFUARD

    MDR report key: 16683518 · Received April 4, 2023

    Report

    Report Number
    MW5116313
    Event Type
    Injury
    Date Received
    April 4, 2023
    Date of Event
    March 9, 2023
    Report Date
    March 30, 2023
    Manufacturer
    APNEA SCIENCES CORPORATION
    Product Code
    LRK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED SNOREMD MOUTH GUARD TO HELP WITH SNORING. IT DID HELP WITH MY SNORING BUT AFTER 4 OR 5 DAYS MY LIPS WERE BURNING AND SWOLLEN. I TOOK CARE OF IT AS DIRECTED SO IT WASN'T ANYTHING I DID. I QUIT WEARING IT FOR A WEEK TO HEAL MY LIPS AND TRIED TO WEAR IT AGAIN THIS WEEK WITH LIP BALM BUT THEY ARE NOW BURNING AGAIN. I CONTACTED THE COMPANY AND AM WAITING TO HEAR BACK. IT'S AN INCREDIBLY PAINFUL REACTION TO SOMETHING THEY USE IN THEIR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519688 SNOREMD MICRO-ADJUSTABLE SNORING MOUTHFUARD DEVICE, ANTI-SNORING LRK APNEA SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other