BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURETTE

    MDR report key: 32912 · Received May 10, 1996

    Report

    Report Number
    MW4001189
    Event Type
    Malfunction
    Date Received
    May 10, 1996
    Report Date
    August 2, 1995
    Manufacturer
    MILTEX INSTRUMENT CO, INC.
    Product Code
    EMN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CURETTE IS INAPPROPRIATE DUE TO ITS SHANK BEING TOO LONG CAUSING TRAUMA TO SURROUNDING TISSUE. THE PROPHY TECHNICIANS ALSO HAVE DIFFICULTY PLACING THE INSTRUMENT BETWEEN THE TEETH (DUE TO SHANK BEING TOO WIDE) THUS CAUSES PT DISCOMFORT AND DOES NOT ALLOW ADEQUATE CLEANING DUE TO INABILITY TO ACHIEVE PROPER ANGLE OF SHANK TO TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURETTE CURETTE EMN MILTEX INSTRUMENT CO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO