BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERBST

    MDR report key: 3944909 · Received July 18, 2014

    Report

    Report Number
    2184045-2014-00004
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    EJF
    PMA / PMN Number
    K923405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR REMOVED THE APPLIANCE, GAVE THE PATIENT SAMPLES OF PEROXYL, AND RECOMMENDED SALT WATER RINSES FOR TREATMENT. TO DATE, THE PATIENT HAS FULLY RECOVERED AND IS DOING FINE. A NEW APPLIANCE WILL BE FABRICATED WITH CONSIDERATION TO PATIENT COMFORT.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT A PATIENT HAD EXPERIENCED GUM INFLAMMATION WHILE WEARING A HERBST APPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421331 HERBST BITE-JUMPING ORTHODONTIC APPLIANCE EJF ALLESEE ORTHODONTIC APPLIANCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R