BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HABIT APPLIANCE

    MDR report key: 1372145 · Received April 30, 2009

    Report

    Report Number
    3004869383-2009-00001
    Event Type
    Injury
    Date Received
    April 30, 2009
    Date of Event
    April 2, 2009
    Report Date
    April 2, 2009
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES - CONNECTICUT
    Product Code
    DYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT RETURNED TO THE DOCTOR'S OFFICE ONE DAY AFTER PLACEMENT OF THE APPLIANCE WITH A SEVERE RASH. THE PATIENT'S PARENTS INFORMED THE DOCTOR THAT THE PATIENT HAS A KNOWN ALLERGY TO NICKEL AND POSSIBLY OTHER METALS. THE DOCTOR REMOVED THE METAL APPLIANCE AND THE PATIENT WENT TO SEE HER PEDIATRIC PHYSICIAN. THE PATIENT WAS GIVEN THREE DOSES OF PREDNISONE STEROID TREATMENT FOR ELEVEN DAYS TO TREAT THE ALLERGIC REACTION. CURRENTLY, THE PATIENT IS DOING WELL AND IS ON A PRESCRIPTION ANTIHISTAMINE, ATARAX, UNTIL THE RASH COMPLETELY CLEARS. ONCE THE RASH HAS COMPLETELY CLEARED, THE PATIENT WILL UNDERGO ALLERGY TESTING BEFORE CONTINUING WITH THE PLANNED ORTHODONTIC TREATMENT. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IN 2009, A DOCTOR REPORTED THAT A PATIENT HAD DEVELOPED A SEVERE RASH ONE DAY AFTER PLACEMENT OF A METAL HABIT APPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HABIT APPLIANCE RETAINER, SCREW EXPANSION, ORTHODONTIC DYJ ALLESEE ORTHODONTIC APPLIANCES - CONNECTICUT

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other