BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXED RAPID PALATAL EXPANDER

    MDR report key: 2552340 · Received April 29, 2012

    Report

    Report Number
    2184045-2012-00006
    Event Type
    Injury
    Date Received
    April 29, 2012
    Report Date
    March 28, 2012
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    DYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR REMOVED THE APPLIANCE AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR TREATMENT. A NEW APPLIANCE WAS FABRICATED WITH THE PALATAL ACRYLIC PLACED CLOSER TO THE PALATE, FOR PATIENT COMFORT. TO DATE, THE PATIENT IS DOING FINE AND HAS FULLY RECOVERED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT A PATIENT EXPERIENCED TISSUE IRRITATION WHILE WEARING THE FIXED RAPID PALATAL EXPANDER APPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXED RAPID PALATAL EXPANDER RETAINER, SCREW EXPANSION, ORTHODONTIC DYJ ALLESEE ORTHODONTIC APPLIANCES

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other| R