BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERBST

    MDR report key: 2493333 · Received March 15, 2012

    Report

    Report Number
    2184045-2012-00004
    Event Type
    Injury
    Date Received
    March 15, 2012
    Report Date
    February 14, 2012
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    EJF
    PMA / PMN Number
    K923405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS PRESCRIBED CHLORHEXIDINE, AN ANTISEPTIC RINSE, FOR TREATMENT. THE DOCTOR'S OFFICE STATED THAT THE NEW APPLIANCE WILL NOT BE PLACED AT THE MOMENT. THE PATIENT'S PARENTS WILL DECIDE WHETHER THE APPLIANCE SHOULD BE PLACED OR NOT, AFTER MEETING WITH THE DOCTOR. TO DATE, THE PATIENT IS DOING FINE. THE APPLIANCE WAS NOT RETURNED, THEREFORE, NO EVALUATION OF THE APPLIANCE COULD BE CONDUCTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT UPPER PORTION OF THE HERBST IS CAUSING SORES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other