BEUDAMED
    FDA Adverse Event Summary report: N

    FACE BOW

    MDR report key: 972999 · Received November 8, 2005

    Report

    Report Number
    2126683-2005-00001
    Date Received
    November 8, 2005
    Date of Event
    August 18, 2002
    Report Date
    January 27, 2005
    Manufacturer
    AMERICAN ORTHODONTICS
    Product Code
    DZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIC PATIENT WITH OCULAR INJURY DUE TO HEADGEAR - WE ARE STILL UNAWARE OF ALL FACTS AS THIS CASE RECENTLY CAME TO LITIGATION. BLINDNESS IN ONE EYE AND IMPAIRED VISION IN THE OTHER. THE HEADGEAR DOES NOT APPEAR TO BE DEFECTIVE NOR DO THE SAFETY RELEASE MODULES OR HEAD STRAP. PRELIMINARY INFORMATION SUGGESTS INSTRUCTIONS FROM THE DR. AND IMPROPER REMOVAL OF THE HEADGEAR BY THE PATIENT ARE SIGNIFICANT FACTORS IN THIS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FACE BOW HEAD GEAR DZB AMERICAN ORTHODONTICS 300 SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| S