BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNORE RX

    MDR report key: 8071031 · Received November 13, 2018

    Report

    Report Number
    MW5081263
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    August 20, 2018
    Report Date
    November 8, 2018
    Manufacturer
    APNEA SCIENCES CORPORATION
    Product Code
    LRK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A "SNORE RX" DEVICE. I USED THE DEVICE ACCORDING TO MFR INSTRUCTIONS. IN LESS THAN A YEAR, I HAD INTENSE JAW PAIN AND THE INABILITY TO CLOSE AND CLENCH MY TEETH TOGETHER. AS A RESULT OF USING THE DEVICE, MY QUALITY OF LIFE HAS BEEN SEVERELY IMPACTED. INABILITY TO FULLY CHEW FOOD ITEMS, CONSTANT JAW PAIN AND INFLAMMATION. SIGNIFICANT EXPENSES ASSOCIATED WITH TREATMENT FOR COMFORT AND PAIN. I HAVE BEEN WORKING WITH MY DENTIST, MAXILLOFACIAL SURGEON AND NOW, ORTHODONTIST TO CORRECT THE MOVEMENT MY TEETH HAVE GONE THROUGH AND TO TREAT SIGNIFICANT PAIN. A $(B)(6) DEVICE WILL COST ME AROUND $(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902594 SNORE RX DEVICE, ANTI-SNORING-SNORERX LRK APNEA SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention