BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERBST APPLIANCE

    MDR report key: 931656 · Received October 24, 2007

    Report

    Report Number
    2184045-2007-00004
    Event Type
    Injury
    Date Received
    October 24, 2007
    Date of Event
    October 1, 2007
    Report Date
    October 1, 2007
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    DYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE APPLIANCE MAY HAVE AGGRAVATED THE PT'S EXISTING SALIVATING DISORDER CAUSING IRRITATION DUE TO THE EXCESS SALIVA. THE DOCTOR PRESCRIBED A TOPICAL OINTMENT FOR THE IRRITATION IN 2007. THE MEDICATION RESOLVED THE IRRITATION. THE PT IS NOW DOING FINE AND CONTINUES TO USE THE DEVICE.

    Description of Event or Problem · 1

    THE DOCTOR INFORMED ALLESEE ORTHODONTIC APPLIANCES THAT THE PT MAY BE SHOWING SIGNS OF A REACTION TO THE HERBST APPLIANCE. THE PT HAS BEEN SALIVATING HEAVILY SINCE THE PLACEMENT OF THE APPLIANCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention