BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANS-PALATAL ARCH (TPA) APPLIANCE

    MDR report key: 1251343 · Received December 5, 2008

    Report

    Report Number
    2184045-2008-00003
    Event Type
    Injury
    Date Received
    December 5, 2008
    Report Date
    November 10, 2008
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    DYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT THE PATIENT'S PEDIATRIC DENTIST NOTICED THE BLUEISH DISCOLORATION DURING A ROUTINE CHECK-UP. THE DENTIST OBSERVED THE DISCOLORATION FOR TWO WEEKS AND BELIEVES IT IS HARMLESS TO THE PATIENT. THE DOCTOR REPORTED THAT IT APPEARS TO BE A TYPE OF PERMANENT TATTOO (SIMILAR TO AN AMALGAM TATTOO) ISOLATED TO WHERE THE SOLDER OF THE STAINLESS STEEL APPLIANCE WAS IN CONTACT WITH THE PATIENT'S PALATAL TISSUE. ACCORDING TO THE DOCTOR THE DISCOLORATION IS HARMLESS AND SINCE IT IS ONLY VISIBLE INSIDE THE PATIENT'S MOUTH ON THE INNER PALATAL TISSUE, IT DOES NOT CREATE ANY AESTHETIC PROBLEMS FOR THE PATIENT. THE PATIENT IS DOING FINE AND HAS HAD THE APPLIANCE REMOVED SINCE 2008. THE PATIENT WORE THE APPLIANCE FOR APPROXIMATELY FOUR YEARS. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IN 2008, A DOCTOR REPORTED THAT A PATIENT HAD DEVELOPED A BLUEISH DISCOLORATION ON HIS PALATAL TISSUE IN HIS MOUTH FROM WEARING THE TRANS-PALATAL ARCH (TPA) APPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANS-PALATAL ARCH (TPA) APPLIANCE RETAINER, SCREW EXPANSION, ORTHODONTIC DYJ ALLESEE ORTHODONTIC APPLIANCES

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other