BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERBST

    MDR report key: 2908503 · Received January 10, 2013

    Report

    Report Number
    2184045-2013-00001
    Event Type
    Injury
    Date Received
    January 10, 2013
    Report Date
    December 13, 2012
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    EJF
    PMA / PMN Number
    K923405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE APPLIANCE WAS REMOVED AND THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC OINTMENT (LYSINE) AND AN ORAL RINSE SOLUTION (PEROXYL) FOR TREATMENT. A NEW APPLIANCE WAS FABRICATED AND HAS BEEN PLACED, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE AND HAS FULLY RECOVERED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT A PATIENT HAD EXPERIENCED IRRITATION OF THE TONGUE DUE TO THE POSITION OF THE TPA WIRE ON THE HERBST DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15448 HERBST BITE-JUMPING ORTHODONTIC APPLIANCE EJF ALLESEE ORTHODONTIC APPLIANCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R