BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAMON UTILITY OPENING/CLOSING PLIER

    MDR report key: 660221 · Received January 2, 2006

    Report

    Report Number
    2016150-2005-00046
    Event Type
    Malfunction
    Date Received
    January 2, 2006
    Date of Event
    December 1, 2005
    Report Date
    December 5, 2005
    Manufacturer
    ORMCO CORP.
    Product Code
    JEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN DECEMBER 2005 ONE DAMON UTILITY OPENING/CLOSING PLIER HAD A BROKEN TIP INSERT, BRAZE FAILURE. THERE WERE NO REPORTED PT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAMON UTILITY OPENING/CLOSING PLIER PLIER, ORTHODONTIC JEX ORMCO CORP. NA 04L37L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other