BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIJECT PLUS

    MDR report key: 212182 · Received March 1, 1999

    Report

    Report Number
    1412902-1999-00005
    Event Type
    Injury
    Date Received
    March 1, 1999
    Report Date
    February 26, 1999
    Manufacturer
    MPL TECHNOLOGIES
    Product Code
    DZM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE INJECTION, UPON REMOVING THE SYRINGE IT WAS IMMEDIATELY NOTED THAT THE NEEDLE PORTION WAS MISSING FROM THE HUB. AN X-RAY INDICATED THE PRESENCE OF THE NEEDLE IN THE PTERYGOMANDIBULAR REGION. FOLLOWING THE INCIDENT, AN ORAL SURGEON SUCCESSFULLY RETRIEVED THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIJECT PLUS DENTAL NEEDLE DZM MPL TECHNOLOGIES 30G SHORT 12711

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention