BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPL NEEDLE

    MDR report key: 411695 · Received August 14, 2002

    Report

    Report Number
    1412902-2002-00038
    Event Type
    Malfunction
    Date Received
    August 14, 2002
    Date of Event
    June 17, 1997
    Report Date
    August 14, 2002
    Manufacturer
    MPL TECHNOLOGIES
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THAT WHILE DENTIST WAS PERFORMING A LEFT MANDIBULAR BLOCK INJECTION, THE NEEDLE BROKE AND LODGED IN PATIENT'S JAW. THE DENTIST COULD NOT RETRIEVE THE NEEDLE AND THUS, SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPL NEEDLE NEEDLE FMI MPL TECHNOLOGIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| R