BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABIDENT

    MDR report key: 362077 · Received November 21, 2001

    Report

    Report Number
    MW1023450
    Event Type
    Malfunction
    Date Received
    November 21, 2001
    Report Date
    November 21, 2001
    Manufacturer
    FAIRFAX DENTAL INC
    Product Code
    DZM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    RPTR HAS SEEN TWO CASES IN THE LAST MONTH WHERE FISTULAS APPEARED AFTER THE USE OF A STABIDENT INJECTION OF LOCAL ANESTHETIC IN THE POSTERIOR MANDIBLE. THESE WERE SELF LIMITING AND SHOULD RESOLVE WITHOUT ANY LONG LASTING ADVERSE EFFECT. THEY COULD BE CONFUSED WITH ENDODONTIC ABSCESSES. WHEN FISTULAS APPEAR ON THE POSTERIOR MANDIBLE, THE TEETH SHOULD BE PULP TESTED BEFORE ENDONTICS IS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52945 STABIDENT INTRAOSSEOUS ANESTHESIA DZM FAIRFAX DENTAL INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other