BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPUDENT STA

    MDR report key: 1998668 · Received January 31, 2011

    Report

    Report Number
    3004082685-2011-00003
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    October 8, 2010
    Report Date
    January 26, 2011
    Manufacturer
    MILESTONE SCIENTIFIC
    Product Code
    EJI
    PMA / PMN Number
    K061904
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6), A PRACTICING DENTIST IN THE (B)(6) MADE A COMPLAINT REGARDING TWO OF HIS PTS WHO HAD ADVERSE TISSUE REACTIONS AFTER P-ASA INJECTIONS WITH THE STA (SINGLE TOOTH ANESTHESIA) INSTRUMENT. THE PTS COMPLAINED OF POST-OPERATIVE DISCOMFORT AND MINOR TISSUE ULCERATION AT THE SITE OF THE INJECTIONS; ALL CONDITIONS HAVE BEEN RESOLVED WITH NO PERMANENT TISSUE DAMAGE. ADVERSE TISSUE REACTIONS ASSOCIATED WITH THE P-ASA INJECTION HAVE BEEN VERY RARELY REPORTED OVER THE LAST TWELVE YEARS, AND THE CAUSE OF THE POST-OPERATIVE COMPLICATION IN QUESTION SHOULD NOT BE ATTRIBUTED TO THE STA, BUT TO ONE OR A COMBINATION OF THE FOLLOWING CAUSATIVE FACTORS. EXCESSIVE VOLUME OF ANESTHETIC DELIVERED, ESPECIALLY WITH 4% DRUGS; EXCESSIVE FLOW RATE OF ANESTHETIC DELIVERED; EXCESSIVE CONCENTRATION OF EPINEPHRINE DELIVERED; AN ERROR IN INJECTION TECHNIQUE, SUCH AS AN INJECTION DIRECTLY INTO THE NASO-PALATINE PAPILLA OR TISSUE RATHER THAN INTO THE NASO-PALATINE CANAL; THE ANESTHETIC CAUSED AN UNTOWARD IATROGENIC REACTION FOR REASONS THAT CANNOT BE DETERMINED.

    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 REPORTED THAT PALATAL INFILTRATIONS RESULTED IN ULCERATION TO THE PALATE BETWEEN THE UPPER TEETH AND INCISIVE PAPILLA. THE CASE WAS IN AN ACTIVE SMOKER OR RECENTLY STOPPED SMOKER. THE CASE RESOLVED SPONTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPUDENT STA EJI MILESTONE SCIENTIFIC STA-5220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other