BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPUDENT STA

    MDR report key: 1340099 · Received February 19, 2009

    Report

    Report Number
    3004082685-2009-00001
    Event Type
    Injury
    Date Received
    February 19, 2009
    Report Date
    February 18, 2009
    Manufacturer
    MILESTONE SCIENTIFIC, INC.
    Product Code
    EJI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    I HAVE ATTACHED A REPORT FROM DR, DIRECTOR OF FROM THE COMPUDENT-STA OPERATORS MANUAL. IN DR'S REPORT, HE OUTLINES HIS CONTACTS WITH THE DENTIST AND HIS CONCLUSIONS. THE DENTIST STATED TO DR THAT SHE DID NOT READ THE INSTRUCTIONS IN THE MANUAL. AN INITIAL EVALUATION WAS CONDUCTED OF THE UNIT INVOLVED IN THIS EVENT. THE RESULTS OF THIS EVALUATION SHOWED THAT THE UNIT WAS OPERATING PER SPECIFICATION. A MORE DETAILED ANALYSIS OF THE UNIT IS UNDERWAY.

    Description of Event or Problem · 1

    A COMPUDENT-STA UNIT WAS USED IN CONJUNCTION WITH A WAND-STA HANDPIECE TO PERFORM A DENTAL ANESTHETIC INJECTION. THE DENTIST PERFORMING THE INJECTION REPORTED THAT NECROSIS OF TISSUE OCCURRED AT THE INJECTION SITE. THE DENTIST INJECTED INTO A LOWER MOLAR APPROXIMATELY .9ML OF 4% ARTICANE WITH A 1:100,000 CONCENTRATION OF EPINEPHRINE. THE DOSAGE AND EPINEPHRINE CONCENTRATIONS ADMINISTERED BY THE DENTIST IS SPECIFICALLY NOT RECOMMENDED FOR THESE TYPES OF INJECTIONS IN THE OPERATORS MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPUDENT STA EJI MILESTONE SCIENTIFIC, INC. STA-5110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other