BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, ORIGINAL (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GU

    MDR report key: 2281776 · Received October 3, 2011

    Report

    Report Number
    1530449-2011-00165
    Event Type
    Other
    Date Received
    October 3, 2011
    Report Date
    September 15, 2011
    Manufacturer
    PROCTER & GAMBLE CO.
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE REPORTER; THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    CUT PLACE OUT IN ROOF OF MOUTH SIZE OF LITTLE FINGER [PALATAL OPERATION]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, AN ADULT FEMALE AGE UNSPECIFIED, APPLIED FIXODENT DENTURE ADHESIVE, ORIGINAL CREAM TO THE ROOF OF HER MOUTH, UNSPECIFIED TOTAL DAILY USE FOR 20 YEARS OR MORE, AND HAD TO HAVE A PLACE, THE SIZE OF A LITTLE FINGER, CUT FROM THE ROOF OF HER MOUTH 2 YEARS AGO. HER SURGEON SAID THE NEED FOR THE SURGERY WAS DUE TO HER USE OF FIXODENT. THE CASE OUTCOME WAS RECOVERED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - HAS HAD DENTURES FOR 20 YEARS OR MORE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, ORIGINAL (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GU DENTURE ADHESIVE KOO PROCTER & GAMBLE CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other