BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO BOIL NITE PROTECTOR

    MDR report key: 4232962 · Received November 6, 2014

    Report

    Report Number
    1825660-2014-00943
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 6, 2014
    Report Date
    November 5, 2014
    Manufacturer
    RANIR, LLC
    Product Code
    OBR
    PMA / PMN Number
    K091175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER WOKE UP WITH BITS OF PLASTIC IN HER MOUTH THAT HAD BROKEN OFF OF THE PROTECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714624 NO BOIL NITE PROTECTOR MOUTH GUARD OBR RANIR, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1