BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIND NO MORE

    MDR report key: 4338465 · Received December 17, 2014

    Report

    Report Number
    1825660-2014-00977
    Event Type
    Injury
    Date Received
    December 17, 2014
    Date of Event
    December 8, 2014
    Report Date
    December 17, 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

    THE GUARD CUTS HER TONGUE AND THE FRONT PART DIGS INTO HER MOUTH. I LEARNED THAT SHE WAS USED TO WEARING THE STOP GRINDING GUARD AND SHE LOVES THEM. SHE MISTAKENLY BOUGHT THE GRIND NO MORE THINKING THEY WERE THE SAME THING.

    Description of Event or Problem · 1

    THE GUARD CUTS HER TONGUE AND THE FRONT PART DIGS INTO HER MOUTH. SHE WAS USED TO WEARING THE STOP GRINDING GUARD (OTHER PRODUCT) AND SHE LOVES THEM. SHE MISTAKENLY BOUGHT THE GRIND NO MORE THINKING THEY WERE THE SAME THING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828422 GRIND NO MORE NITE GUARD OTC OBR RANIR, LLC GRIND NO MORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other