BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FACE BOW

    MDR report key: 2304440 · Received March 14, 2007

    Report

    Report Number
    2126683-2005-00002
    Event Type
    Injury
    Date Received
    March 14, 2007
    Date of Event
    August 18, 2002
    Report Date
    October 27, 2005
    Manufacturer
    AMERICAN ORTHODONTICS
    Product Code
    DZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY THE ORTHODONTIST AND IMPROPER REMOVAL OF THE HEADGEAR BY THE PT ARE SIGNIFICANT FACTORS IN THIS INJURY.

    Description of Event or Problem · 1

    ORTHODONTIC PT WITH OCULAR INJURY DUE TO HEADGEAR. WE ARE STILL UNAWARE OF ALL FACTS AT THIS CASE RECENTLY CAME TO LITIGATION. BLINDNESS IN ONE EYE; IMPAIRED VISION IN THE OTHER. THE HEADGEAR, SAFETY RELEASE MODULES AND HEAD STRAP NO NOT APPEAR TO BE DEFECTIVE. PRELIMINARY INFO SUGGESTS INSTRUCTIONS GIVEN.

    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