BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADC/QUALA BRAND DENTAL NEEDLE

    MDR report key: 176587 · Received July 10, 1998

    Report

    Report Number
    1412902-1998-00003
    Event Type
    Injury
    Date Received
    July 10, 1998
    Date of Event
    April 28, 1998
    Report Date
    June 29, 1998
    Manufacturer
    MPL TECHNOLOGIES
    Product Code
    DZM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DENTIST STATED THAT HE USED ONE NEEDLE TO PERFORM SEVERAL INJECTIONS: 1) SUBMENTAL BLOCK INJECTION, 2) MAXILLARY UPPER ANTERIOR INFILTRATION, AND 3) INFERIOR ALVELOR MANDIBULAR (LOWER BLOCK) INJECTION. THE DENTIST STATED THAT DURING THE THIRD INJECTION THE NEEDLE BROKE OFF AT THE JUNCTION OF THE NEEDLE AND HUB. THE DENTIST WAS UNABLE TO REMOVE THE NEEDLE AND CONSULTED AN ORAL SURGEON TO REMOVE IT. THE NEEDLE WAS SUCCESSFULLY REMOVED. THERE WERE NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADC/QUALA BRAND DENTAL NEEDLE DENTAL NEEDLE DZM MPL TECHNOLOGIES 30G X-SHORT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention