BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPUDENT STA

    MDR report key: 1543892 · Received November 13, 2009

    Report

    Report Number
    3004082685-2009-00003
    Event Type
    Injury
    Date Received
    November 13, 2009
    Report Date
    October 29, 2009
    Manufacturer
    MILESTONE SCIENTIFIC
    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 FACILITY SPECIALIST. IN REP REPORT, SHE OUTLINES HER CONTACT WITH THE DENTIST AND HER CONCLUSIONS. THE DENTIST STATED TO REP THAT HE HAS EXPERIENCED TISSUE DAMAGE IN THE PAST USING A STANDARD SYRINGE. IT IS REP CONCLUSION, THAT THE DENTIST'S INCONSISTENT AND INCORRECT DOSAGE OF ANESTHETIC CONTRIBUTED TO THE TISSUE DAMAGE. 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 INCONSISTENT DOSAGES OF THE ANESTHETIC DRUG. THE DENTIST ALSO INFORMED FACILITY, THAT HE HAS EXPERIENCED THE SAME TISSUE DAMAGE WHEN INJECTING ANESTHETIC DRUGS USING A STANDARD SYRINGE. THE DENTIST STATED THAT HE PURCHASED THE COMPUDENT STA UNIT IN AN ATTEMPT TO ELIMINATE TISSUE DAMAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other