BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITE PROTECTOR

    MDR report key: 3912910 · Received June 10, 2014

    Report

    Report Number
    1825660-2014-00854
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 5, 2014
    Manufacturer
    RANIR, LLC
    Product Code
    OBR
    PMA / PMN Number
    K120103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER HAD WHAT APPEARED TO BE AN ALLERGIC REACTION TO THE DEVICE. BECAUSE THE REACTION INVOLVED INFLAMMATION AND BURNING SENSATION IN THE ORAL CAVITY IT IS CONSIDERED TO BE A SERIOUS INJURY, EVEN IF ONLY TEMPORARY IN NATURE, AND IS A REPORTABLE EVENT. CONSUMER DID NOT SEEK MEDICAL ATTENTION, AND ANY KNOWN ALLERGIES BY CONSUMER HAVE NOT BEEN CONFIRMED. THE PRODUCT WAS NOT RETURNED TO MANUFACTURER SO AN EVALUATION CANNOT BE PERFORMED AS TO THE ROOT CAUSE.

    Description of Event or Problem · 1

    "CAN YOU TELL ME WHAT THIS NITE GUARD IS MADE OF? I KNOW IT DOES NOT HAVE LATEX OR SILICONE BUT WHAT DOES IT HAVE? I HAVE HAD AN ALLERGIC REACTION TO IT AND I NEED TO FIND OUT WHAT TO AVOID. THANK YOU. MY REACTIONS WERE- MY TONGUE BECAME INFLAMED/RED - LIKE A BURNING FEELING AND THE INSIDE OF MY LIP BECAME ALL SORT OF PUCKERY...I THOUGH IT WAS A FOOD REACTION BUT I TRIED ELIMINATING MANY FOODS TO SEE IF THE SYMPTOMS CHANGED, BUT THEY DID NOT- IT WAS NOT UNTIL I STOPPED WEARING THE NIGHT GUARD THAT THEY DISAPPEARED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337542 NITE PROTECTOR MOUTHGUARD, OVER THE COUNTER OBR RANIR, LLC GEN III 060512

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening