BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN NEEDLE

    MDR report key: 411693 · Received August 14, 2002

    Report

    Report Number
    1412902-2002-00039
    Event Type
    Malfunction
    Date Received
    August 14, 2002
    Report Date
    August 14, 2002
    Manufacturer
    MPL TECHNOLOGIES
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    DENTIST WAS ALLEGEDLY PERFORMING A RIGHT INFERIOR ALVEOLAR INJECTION IN CONJUNCTION WITH AN ALLOY FILLING. DENTIST ALLEGEDLY NOTICED AIR BUBBLES IN THE CARPULE OF ANESTHETIC AND CEASED ADMINISTERING THE INJECTION. UPON WITHDRAWAL, THE DENTIST REPORTS THAT THE NEEDLE WAS NO LONGER ATTACHED TO THE HUB AND WAS LODGED IN PATIENT'S MOUTH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention SYRINGE.