BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 108579 · Received July 23, 1997

    Report

    Report Number
    2018192-1997-90002
    Event Type
    Injury
    Date Received
    July 23, 1997
    Date of Event
    November 30, 1988
    Report Date
    July 23, 1997
    Manufacturer
    "A" COMPANY ORTHODONTICS
    Product Code
    DZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGED BY A STATEMENT OF CLAIM THAT A PROTRUDING METAL COMPONENT OF THE HEADGEAR STABBED THE PT IN THE EYE WHILE HE WAS REMOVING THE HEADGEAR. THE CLAIM STATES THAT THE PT UNDERWENT VARIOUS TREATMENTS IN 1988 AND ULTIMATELY THE EYE WAS REMOVED IN 1/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE FACEBOW DZB "A" COMPANY ORTHODONTICS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Disability IT WAS ANOTHER MANUFACTURER'S.| ELASTIC HEADGEAR USED IS UNK. CLAIM IMPLIES THAT