BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABIDENT

    MDR report key: 19568 · Received February 9, 1995

    Report

    Report Number
    MW1005081
    Event Type
    Malfunction
    Date Received
    February 9, 1995
    Report Date
    January 31, 1995
    Manufacturer
    FAIRFAX DENTAL, INC.
    Product Code
    DZM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PRODUCT INSTRUCTIONS RECOMMEND BENDING OF NEEDLE AT HUB. NEEDLE SHEATH DOES NOT PREVENT THE NEEDLE FROM BEING A HAZARD. THE NEEDLE PIERCES THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABIDENT LOCAL ANESTHESIA SYSTEM DZM FAIRFAX DENTAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other