BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATTERSON DENTAL NEEDLE

    MDR report key: 316248 · Received February 14, 2001

    Report

    Report Number
    1412902-2001-00002
    Event Type
    Injury
    Date Received
    February 14, 2001
    Date of Event
    September 8, 2000
    Report Date
    February 2, 2001
    Manufacturer
    MPL TECHNOLOGIES
    Product Code
    DZM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE PT WAS AT THE DENTAL OFFICE TO HAVE THE LOWER RIGHT SECOND MOLAR EXTRACTED. AT THE TIME OF THE INJECTION OF THE LOCAL ANESTHETIC, THE NEEDLE BROKE OFF AT THE HUB AND WAS LOST BENEATH THE SUBCUTANEOUS TISSUE. A PANORAMIC X-RAY WAS OBTAINED WHICH SHOWED THE NEEDLE LYING IN THE SOFT TISSUE TRANSVERSELY AT THE LEVEL OF THE LINGULA. ON EXAMINATION IT WAS NOT POSSIBLE TO PALPATE THE NEEDLE TIP AND THE DENTIST FELT REMOVAL WOULD REQUIRE GENERAL ANESTHESIA. CONSEQUENTLY, LATER THAT EVENING UNDER GENERAL ANESTHESIA AS AN OUTPATIENT AT AKRON GENERAL MEDICAL CENTER THE NEEDLE WAS LOCATED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5823 PATTERSON DENTAL NEEDLE DENTAL NEEDLE DZM MPL TECHNOLOGIES 30G SHORT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention