BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOOTH CONDITIONER GEL

    MDR report key: 373968 · Received January 22, 2002

    Report

    Report Number
    2515379-2002-00004
    Event Type
    Malfunction
    Date Received
    January 22, 2002
    Date of Event
    January 16, 2002
    Report Date
    January 21, 2002
    Manufacturer
    L.D. CAULK
    Product Code
    EBC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINT COULD NOT BE REPRODUCED WHEN RETURN SAMPLES (WHERE PROVIDED) AND/OR RETAIN SAMPLES WERE EVALUATED. THEREFORE, CO DID NOT POSITIVELY IDENTIFY ANY FAILURE MODE OR MECHANISM.

    Description of Event or Problem · 1

    TIPS WERE ATTACHED TO THE SYRINGES AND THE SYRINGES WERE THEN EXTRUDED. THERE IS NO FORMALLY DOCUMENTED METHOD FOR THIS ECTRUSION TEST; IT IS GENERALLY ASSOCIATED WITH APPEARANCE METHOD GM-062-89.

    Description of Event or Problem · 1

    SINCE THE ALLEGED DEFECT COULD NOT BE REPRODUCED INTERNALLY, CO'S CONCLUSION IS THAT THE DOCTOR DID NOT PROPERLY ATTACH THE TIP TO THE FILLED SYRINGE. ALSO, THE DIRECTIONS FOR USE STATE "GEL SHOULD FLOW FREELY WITH GENTLE PRESSURE. DO NOT USE EXCESSIVE FORCE. IF NOT , REMOVE SYRINGE FROM PT FIELD AND CHECK FOR OBSTRUCTION." FAILURE TO FOLLOW THESE INSTRUCTIONS COULD LEAD TO THE COMPLAINTS OF TIPS COMING OFF. THE DIRECTIONS FOR USE ALSO STATE TO "DISCARD NEEDLES AFTER USE, AS NEEDLES MAY CLOG IF GEL IS ALLOWED TO DRY INSIDE." CLOGGED TIPS COULD CREATE THE NEED FOR EXCESSIVE FORCE, LEADING TO POTENTIAL FAILURE.

    Description of Event or Problem · 1

    THE DISPENSING TIP CAME OFF OF THE SYRINGE IN THE PATIENT'S MOUTH. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOOTH CONDITIONER GEL DENTAL RESTORATIVE MATERIAL EBC L.D. CAULK NA 010531

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other