BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA)

    MDR report key: 1621490 · Received March 3, 2010

    Report

    Report Number
    2184045-2010-00001
    Event Type
    Injury
    Date Received
    March 3, 2010
    Report Date
    February 4, 2010
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    KMY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PRODUCT WAS IRRITATING THE PATIENT'S CHEEK, CAUSING SEVERE SORES AND AN INFECTION. THE DOCTOR PRESCRIBED ANTIBIOTICS TO TREAT THE INFECTION. THE PATIENT IS DOING FINE AND WILL BE FITTED WITH THE NEW APPLIANCE. THIS IS THE FINAL REPORT. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON FEBRUARY 4, 2010, A DOCTOR REPORTED THAT A PATIENT DEVELOPED SEVERE MOUTH SORES 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