BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAMON UTILITY OPENING/CLOSING PLIER

    MDR report key: 830062 · Received March 8, 2007

    Report

    Report Number
    2016150-2007-00007
    Event Type
    Malfunction
    Date Received
    March 8, 2007
    Date of Event
    February 1, 2007
    Report Date
    February 22, 2007
    Manufacturer
    ORMCO CORP.
    Product Code
    JEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED INJURIES ASSOCIATED WITH THIS INCIDENT. HOWEVER, DUE TO THE PRIOR SUBMISSION OF A REPORTABLE INCIDENT ON THE DAMON PLIER ON MAY 13, 2005, (MDR #2016150-2005-00001: MALFUNCTION WHICH LED TO A SERIOUS INJURY), THIS INCIDENT IS REPORTABLE. THIS INCIDENT FALLS UNDER THE FDA PRESUMPTION THAT THIS TYPE OF MALFUNCTION IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IN FEBRUARY 2007, A DOCTOR INFORMED ORMCO CORPORATION THAT DAMON OPENING/CLOSING PLIER HAD A BROKEN TIP INSERT, BRAZE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAMON UTILITY OPENING/CLOSING PLIER PLIER, ORTHODONTIC JEX ORMCO CORP. * 04K45K

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other