BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUALA

    MDR report key: 49168 · Received November 15, 1996

    Report

    Report Number
    1412902-1996-00003
    Event Type
    Injury
    Date Received
    November 15, 1996
    Date of Event
    October 21, 1996
    Report Date
    October 28, 1996
    Manufacturer
    MPL TECHNOLOGIES, INC.
    Product Code
    DZM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN INFERIOR ALVEOLAR (RIGHT MANDIBULAR BLOCK) INJECTION IN THE PT'S LOWER JAW BEHIND THE SECOND MOLAR, DR FELT SOME PUSH ON THE BONE AND WHILE ATTEMPTING TO PULL OUT THE NEEDLE, IT SEPARATED FROM THE HUB. NEEDLE WAS SURGICALLY REMOVED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUALA DENTAL NEEDLE DZM MPL TECHNOLOGIES, INC. DP47830 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention