BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENUS TEMP C&B

    MDR report key: 1950862 · Received November 24, 2010

    Report

    Report Number
    1925223-2010-00004
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 24, 2010
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EMA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    OFFICE HAS 5 CARTRIDGES OF VENUS TEMP C&B THAT ARE CAUSING IRRITATING GUM TISSUE AND SWOLLEN AND BLEEDING GUMS FROM BEING TOO GREASY. VENUS TEMP C&B SHADE A1 LOT 7804288 QTY 1 EXPIRED 4/10. VENUS TEMP C&B SHADE A2 LOT 7803267 QTY 2 EXPIRED 3/10. VENUS TEMP C&B SHADE A3.5 LOT 7804381 QTY 1 EXPIRED 6/10. VENUS TEMP C&B SHADE A3.5 LOT 7806580 QTY 1 EXPIRED 7/10. THREE PTS THAT HAVE HAD VERY SWOLLEN AND BLEEDING GUMS, MOSTLY ON BRIDGE PREPS. TWO OF THE 3 PT'S CALLED AND CAME IN ON AN EMERGENCY BASIS TO BE SEEN FOR THEIR GUM TISSUE. THE FIRST PT IS FEMALE IN HER EARLY (B)(6). THEY DID AN ANTERIOR BRIDGE PREP ON ABUTMENT TEETH NUMBERS 7 AND 14 WITH PONTICS 8 THROUGH 13 IN (B)(6) 2010. THE PT CALLED BACK ABOUT A WEEK LATER TO COMPLAIN OF HOW HER GUM TISSUE LOOKED, IT WAS SWOLLEN AND RED. THE DOCTOR REMOVED THE TEMPORARY AND CUT OUT THE PONTICS. HE USED PERIDEX AND PERFORMED A GINGIVECTOMY ON THE GINGIVA IN THE PONTIC REGION. THE DOCTOR PUT THE TEMPORARIES BACK ON WITH TEMPORARY CEMENT AND HAD HER COME BACK IN A WEEK TO CHECK THE PROGRESS. THE PT LOOKED MUCH BETTER AFTER THE WEEK AND THEY RESCHEDULED HER TO COME IN ON THURSDAY OR TUESDAY OF NEXT WEEK FOR THE FINAL CEMENT OF THE BRIDGE. THE PT DID NOT SEE A MEDICAL DOCTOR AND THE DENTIST DID NOT PRESCRIBE ANYTHING FOR HER TO USE. THE PT HAS GOOD HYGIENE AND GOOD PERIO MAINTENANCE. THE OXYGEN INHIBITING LAYER WAS REMOVED PRIOR TO SEATING BY GRINDING AND POLISHING.

    Description of Event or Problem · 2

    OFFICE HAS 5 CARTRIDGES OF VENUS TEMP C&B THAT ARE CAUSING IRRITATING GUM TISSUE AND SWOLLEN AND BLEEDING GUMS FROM BEING TOO GREASY. VENUS TEMP C&B SHADE A1 LOT 7804288 QTY 1 EXPIRED 4/10. VENUS TEMP C&B SHADE A2 LOT 7803267 QTY 2 EXPIRED 3/10. VENUS TEMP C&B SHADE A3.5 LOT 7804381 QTY 1 EXPIRED 6/10. VENUS TEMP C&B SHADE A3.5 LOT 7806580 QTY 1 EXPIRED 7/10. THREE PTS THAT HAVE HAD VERY SWOLLEN AND BLEEDING GUMS, MOSTLY ON BRIDGE PREPS. TWO OF THE 3 PT'S CALLED AND CAME IN ON AN EMERGENCY BASIS TO BE SEEN FOR THEIR GUM TISSUE. PT NUMBER 2 IS A FEMALE IN HER (B)(6) THAT CAME IN WITH AN IMPLANT WHERE NUMBER 9 WAS REMOVED DUE TO A FRACTURED ROOT. THEY USED THE VENUS TEMP C&B AS A TEMPORARY MATERIAL FOR THE IMPLANT AND A 6 UNIT BRIDGE FROM TEETH 6 TO 11. THE PT CALLED ABOUT A WEEK AFTER THE PREP APPOINTMENTS COMPLAINING OF RED, SWOLLEN, AND SORE GUMS. THE DENTIST REMOVED THE VENUS TEMP C&B TEMPORARIES AND REPLACED WITH PROTEMP. THE REDNESS WAS MAINLY INTERPROXIMAL. THIS OCCURRED ABOUT 2 WEEKS AGO SHE THOUGH BUT NO MORE THAN 3 WEEKS AGO. THE PT IS COMING IN ON THURSDAY FOR THE SEATING APPOINTMENT. THE OXYGEN INHIBITING LAYER WAS REMOVED PRIOR TO SEATING. THE PT HAS GOOD ORAL HYGIENE AND GOOD PERIO.

    Description of Event or Problem · 3

    OFFICE HAS 5 CARTRIDGES OF VENUS TEMP C&B THAT ARE CAUSING IRRITATING GUM TISSUE AND SWOLLEN AND BLEEDING GUMS FROM BEING TOO GREASY. VENUS TEMP C&B SHADE A1 LOT 7804288 QTY 1 EXPIRED 4/10. VENUS TEMP C&B SHADE A2 LOT 7803267 QTY 2 EXPIRED 3/10. VENUS TEMP C&B SHADE A3.5 LOT 7804381 QTY 1 EXPIRED 6/10. VENUS TEMP C&B SHADE A3.5 LOT 7806580 QTY 1 EXPIRED 7/10. THREE PTS THAT HAVE HAD VERY SWOLLEN AND BLEEDING GUMS, MOSTLY ON BRIDGE PREPS. TWO OF THE 3 PT'S CALLED AND CAME IN ON AN EMERGENCY BASIS TO BE SEEN FOR THEIR GUM TISSUE. THE THIRD PT IS A MALE IN HIS (B)(6) THAT STEPHANIE THOUGHT CAME IN ABOUT 2 MONTHS AGO. THEY WORKED ON HIS UR QUADRANT AND THE PT DID NOT COME BACK FOR AN EMERGENCY APPOINTMENT. THEY NOTICED THE REDNESS AND SWELLING OF THE DELIVERY APPOINTMENT. THE DOCTOR USED TEMPORARY CEMENT TO SEAT THE BRIDGE AND THE PT CAME BACK TO HAVE IT SEATED PERMANENTLY AFTER THE GINGIVA RETURNED TO NORMAL. SHE HAS NOT HEARD BACK FROM THIS PT SINCE THAT FINAL SEATING APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENUS TEMP C&B TEMPORARY CEMENT EMA HERAEUS KULZER GMBH VARIOUS VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention
    2 Required Intervention
    3 Required Intervention