BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATTERSON

    MDR report key: 212704 · Received February 26, 1999

    Report

    Report Number
    1412902-1999-00004
    Event Type
    Malfunction
    Date Received
    February 26, 1999
    Date of Event
    January 19, 1999
    Report Date
    January 22, 1999
    Manufacturer
    MPL TECHNOLOGIES
    Product Code
    DZM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A LOWER MANDIBULAR BLOCK INJECTION (INFERIOR ALVEOLAR) FOR RESTORATION ON TOOTH #19, THE NEEDLE WAS INSERTED INTO THE GUM TISSUE UP TO ONE MILLIMETER. THE PATIENT COUGHED AND THE NEEDLE IMMEDIATELY DISAPPEARED INTO THE PATIENT'S TISSUE AND BROKE AT THE JUNCTION OF THE NEEDLE UNSUCCESSFULLY. THE PATIENT WAS IMMEDIATELY REFERRED TO AN ORAL SURGEON WHERE THE NEEDLE WAS SUCCESSFULLY REMOVED. THE PATIENT WAS ADMITTED TO A HOSPITAL FOR OVERNIGHT OBSERVATION. THE PATIENT IS FINE. THERE WERE NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATTERSON DENTAL NEEDLE DZM MPL TECHNOLOGIES 30G SHORT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention