BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAMON UTILITY OPENING/CLOSING PLIER

    MDR report key: 602698 · Received May 13, 2005

    Report

    Report Number
    2016150-2005-00001
    Event Type
    Injury
    Date Received
    May 13, 2005
    Date of Event
    April 26, 2005
    Report Date
    May 3, 2005
    Manufacturer
    ORMCO CORP.
    Product Code
    JEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2005 WHILE PLACING AND SECURING THE ARCHWIRE, THE TIP OF THE DAMON UTILITY OPENING/CLOSING PLIER SEPARATED AND THE PLIER STRUCK THE PT'S LOWER RIGHT CENTRAL INCISOR, TOOTH #25, FRACTURING IT APPROXIMATELY 1-1.5MM SUPRAGINGIVAL, EXPOSING THE DENTAL PULP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAMON UTILITY OPENING/CLOSING PLIER PLIER, ORTHODONTIC JEX ORMCO CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other