BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUALA DENTAL NEEDLE

    MDR report key: 371077 · Received January 10, 2002

    Report

    Report Number
    1412902-2002-00001
    Event Type
    Other
    Date Received
    January 10, 2002
    Date of Event
    May 24, 2001
    Report Date
    January 7, 2002
    Manufacturer
    MPL TECHNOLOGIES
    Product Code
    DZM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NEEDLE BROKE UPON INITIAL INJECTION IN A PT. THE PT WAS REFERRED TO AN ORAL SURGEON TO FIND AND REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUALA DENTAL NEEDLE DENTAL NEEDLE DZM MPL TECHNOLOGIES 30G SHORT 13414 OR 13416

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention