BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA)

    MDR report key: 1561490 · Received December 17, 2009

    Report

    Report Number
    2184045-2009-00003
    Event Type
    Injury
    Date Received
    December 17, 2009
    Report Date
    November 18, 2009
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    KMY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE EACH APPLIANCE IS CUSTOM MADE TO THE REQUEST OF THE PRESCRIPTION, THERE WAS NO PRODUCT PROBLEM. THE DOCTOR HAS REQUESTED THAT A NEW APPLIANCE BE FABRICATED OF A DIFFERENT DESIGN FOR THE PATIENT'S COMFORT. THE NATURE OF THE PRODUCT WAS IRRITATING THE PATIENT'S CHEEK. THE DOCTOR PRESCRIBED ANTIBIOTICS TO HELP HEAL THE CHEEK ULCERS AND ANY INFECTION. THE PATIENT'S ULCERS HAVE NOW COMPLETELY HEALED, AND THE PATIENT IS DOING FINE. THE PATIENT WILL BE FITTED WITH THE NEW APPLIANCE AT HIS NEXT APPOINTMENT.THIS IS THE FINAL REPORT. NO DEVICE PROBLEM.

    Description of Event or Problem · 1

    ON NOVEMBER 18, 2009, A DOCTOR REPORTED THAT A PATIENT DEVELOPED CHEEK ULCERS DUE TO IRRITATION FROM WEARING THE MARA APPLIANCE AND NEEDED TO TAKE ANTIBIOTICS FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA) POSITIONER, TOOTH, PREFORMED KMY ALLESEE ORTHODONTIC APPLIANCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other