BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIND NO MORE

    MDR report key: 4190623 · Received October 21, 2014

    Report

    Report Number
    1825660-2014-00929
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 15, 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

    CONSUMER STATED HE SWALLOWED THE GUARD LAST NIGHT AND DOESN'T KNOW IF HE SHOULD GO TO THE DOCTOR. IS IT HARMFUL TO HIS BODY?

    Description of Event or Problem · 1

    STATED HE SWALLOWED THE GUARD LAST NIGHT AND DOESN'T KNOW IF HE SHOULD GO TO THE DOCTOR. IS IT HARMFUL TO HIS BODY?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667438 GRIND NO MORE NITE GUARD OTC OBR RANIR, LLC GRIND NO MORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other