BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIND NO MORE

    MDR report key: 4101436 · Received September 19, 2014

    Report

    Report Number
    1825660-2014-00913
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 18, 2014
    Manufacturer
    RANIR, LLC
    Product Code
    OBR
    PMA / PMN Number
    K091175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED AS AN ALLEGED ALLERGIC RESPONSE. MEDICAL INTERVENTION MAY BE REQUIRED IF THE DEVICE CONTAINS SENSITIZING MATERIAL.

    Description of Event or Problem · 1

    "I PURCHASED YOUR BITE GUARD. I AM IN AN ALLERGY CLINIC THE NEXT COUPLE DAYS AND I AM ALLERGIC TO THAT AND THEY CAN FIX THE ALLERGY. CAN YOU TELL ME IF THAT'S PLASTIC OR NYLON OR WHAT MATERIAL IT'S MADE OUT OF? I NEED TO KNOW THAT." CONSUMER FURTHER STATED THAT THE GUARD IS CAUSING IRRITATION AND INFECTION TO HER GUMS WHICH IS NOT GOING AWAY. SHE WENT TO THE ALLERGY CLINIC AND WAS TOLD IT IS MOSTLY A REACTION TO THE MATERIAL. SHE WORE IT FOR MONTHS BEFORE INFECTION/IRRITATION OCCURRED AND SHE SOAKS THEM IN PEROXIDE EVERY DAY FOR CLEANING/MAINTENANCE. SHE IS ALLERGIC TO NYLON AND WILL BE GOING BACK TO THE ALLERGY CLINIC ONCE SHE KNOWS THAT MATERIAL FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581617 GRIND NO MORE NITE GUARD OTC OBR RANIR, LLC GRIND NO MORE

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Hospitalization