BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GC FUJITEMP LT

    MDR report key: 2183137 · Received July 28, 2011

    Report

    Report Number
    1410097-2011-00001
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 24, 2011
    Manufacturer
    GC CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K101420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    FIRST 4-5 TIMES DOCTOR USED THE PRODUCT HE FELT IT WAS RUNNY. TALKED WITH DOCTOR TO DISCUSS MIXING TECHNIQUE - TO SPATULATE THE YELLOW MATERIAL FIRST, THEN INCORPORATE THAT INTO THE WHITE MATERIAL TO ASSURE THE THICKER YELLOW MATERIAL IS FULLY INCORPORATED INTO THE COMPLETE MIX OF THE PRODUCT. PATIENT IS GOING TO TRY AND RETRIEVE THE CROWN FROM STOOL. PATIENT'S OVERALL HEALTH IS GOOD. DR. NOTED THAT CROWN WAS RETRIEVED AS INDICATED ABOVE. AS THIS TIME THERE IS NO APPARENT INTERNAL TRAUMA REPORTED BY PATIENT.

    Description of Event or Problem · 1

    DR. REPORTED A PATIENT HAD SWALLOWED A 3-UNIT BRIDGE (2 ABUTMENTS AND ONE PONTIC) THAT WERE CEMENTED WITH FUJITEMP LT. BRIDGE WAS FIRST CEMENTED WITH TEMP GRIP (DENTSPLY CAULK) FOR 5 MONTHS. DR. DECIDED TO REPLACE PREVIOUS CEMENT WITH FUJITEMP LT. HAD NO PROBLEM WITH RETENTION - CLEANED AREA AND MICRO ETCHED THE INSIDE OF THE CROWN. DR. STATED THE PRODUCT WAS RUNNY AND FELT HIS ASSISTANT, WHO HAS WORKED WITH HIM FOR YEARS, MIXED THE PRODUCT CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GC FUJITEMP LT TEMPORARY DENTAL CEMENT EMA GC CORPORATION 101111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other