BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA)

    MDR report key: 2941782 · Received February 4, 2013

    Report

    Report Number
    2184045-2013-00003
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    December 26, 2012
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    KMY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR HAD A NEW UPPER APPLAINCES FABRICATED WITH REGARD TO PATIENT COMFORT. TO DATE, THE PATIENT IS DOING FINE. IT WAS CONFIRMED THAT NO INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, DOCTOR ALLEGED THAT THE MARA APPLIANCE BROKE AT SOLDER JOINT LEAVING A SHARP PIECE IN ONE (1) PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46502 MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA) POSITIONER, TOOTH, PREFORMED KMY ALLESEE ORTHODONTIC APPLIANCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other