BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNORE GUARD ADVANCE

    MDR report key: 2794080 · Received September 28, 2012

    Report

    Report Number
    1825660-2012-00001
    Event Type
    Injury
    Date Received
    September 28, 2012
    Date of Event
    May 7, 2012
    Report Date
    September 12, 2012
    Manufacturer
    RANIR LLC
    Product Code
    LRK
    PMA / PMN Number
    K102118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, SO WE COULD NOT DO AN EVALUATION OF THE ACTUAL DEVICE. OUR QUALIFIED PERSON CONTACTED A DENTIST AND DISCUSSED IF THE DEVICE COULD HAVE CAUSED THE INJURY AS DESCRIBED BY THE CUSTOMER. THE DENTIST SAID THAT IF THE DEVICE WAS USED BY A PERSON WITH CONDYLAR ISSUES THEN IT COULD HAVE RESULTED IN THE CONDITION THAT THE CUSTOMER COMPLAINED ABOUT. IN CONVERSATION WITH OUR CUSTOMER COMPLAINTS DEPARTMENT, THE CUSTOMER STATED THAT SHE HAS USED THIS DEVICE FOR SEVERAL MONTHS. THIS DEVICE IS CONTRACT MANUFACTURED BY PALCO FOR RANIR LLC, THE SPECIFICATIONS DEVELOPER.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED THE MANUFACTURER VIA OUR CONTRACT MARKETER, BY A PRIVATE (B)(4) POSTING. CUSTOMERS SAYS THAT SHE RECEIVED THE SNORE GUARD ANTI-SNORING DEVICE THROUGH HER DENTIST. SHE SAYS THAT THE DEVICE CAUSED DISC DISLOCATION AND DAMAGE, AND THAT SHE WILL REQUIRE TMJ ARTHROCENTESIS. CUSTOMER WAS FITTED FOR THE DEVICE BY HER DENTIST, AND WORE IT FOR SIX MONTHS TO A YEAR BEFORE DEVELOPING TMJ. THIS IS A PRESCRIPTION DEVICE. SPECIFIC WORDS WERE: I WOULD APPRECIATE [SIC] A CALL OR WRITING BACK. MY DENTIST GAVE ME SNORE GUARD AND IT DOES STOP SNORING. HOWEVER, DUE TO THE FORWARD POSITION IT KEEPS YOU IN, I NOW HAVE TO GO THRU ARTHROCENTESIS OF MY JAW TOMORROW [SIC]. I KNOW FOR A FACT IT WAS CAUSE BY MY SNORE GUARD. SO YOU SHOULD INFORM DENTISTS MORE OR SOMETHING. I AM NOT COVERED BY THIS (B)(6) PROCEDURE. I AM NOT SURE IF THERE WILL BE CLASS ACTION LAWSUITS FOR THIS BUT I MAY HAVE TO LOOK INTO IT. I ALSO NEEDED A CT SCAN AND MRI OF MY JAW SHOWING DISC DISLOCATION AND DAMAGE. ONE DAY LATER THE CONSUMER WROTE: O WENT THRU MY ARTHROCENTESIS SIDE ONE TODAY AND I WON'T KNOW FOR A WHILE IF I WILL FEEL RELIEF. I HAVE SO MUCH TO TALK TO YOU ABOUT. THANKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SNORE GUARD ADVANCE ANTI-SNORING DEVICE LRK RANIR LLC SNORE GUARD ADVANCE

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention