BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 4113891 · Received May 1, 2014

    Report

    Report Number
    1825660-2014-00085
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    February 5, 2013
    Report Date
    April 29, 2014
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    PMA / PMN Number
    K091792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS NOT BEEN CONFIRMED. DEVICE NOT RETURNED TO MANUFACTURER. NO INJURY WAS REPORTED, NO MEDICAL ATTENTION WAS REPORTED TO HAVE BEEN SOUGHT. THIS IS BEING REPORTED AS A POSSIBLE DELAMINATION, AS CHOKING IS POSSIBLE AS A RESULT OF DELAMINATION.

    Description of Event or Problem · 1

    PER CUSTOMER COMPLAINTS: RIGHT BEFORE HE WENT TO EVEN BOIL IT THE GUARDS ARE ALREADY DETACHED. THE DRUG STORE INFORMED HIM THAT WAS THE ONLY ONE THAT THEY HAD. NUMBER 771058062578, LOT: 013399. PER CUSTOMER COMPLAINTS REQUESTED REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262330 NITE GUARD MOUTHGUARD, OVER THE COUNTER OBR RANIR LLC GEN II ORIG 013399

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening