BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANSYNC

    MDR report key: 2424282 · Received January 20, 2012

    Report

    Report Number
    2016150-2012-00006
    Event Type
    Injury
    Date Received
    January 20, 2012
    Report Date
    December 21, 2011
    Manufacturer
    ORMCO CORPORATION
    Product Code
    EJF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC (AMOXICILLIN) FOR TREATMENT OF THE PATIENT'S CHEEK. TO DATE, THE PATIENT IS DOING FINE AND HAS FULLY RECOVERED. MODIFICATIONS TO THE EXISTING APPLIANCE WILL BE MADE WITH REGARD TO PATIENT COMFORT.

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT THE ADVANSYNC APPLIANCE WAS CAUSING THE INSIDE OF A PATIENT'S LEFT CHEEK TO BE CUT UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANSYNC BITE-JUMPING ORTHODONTIC APPLIANCE EJF ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other