BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU

    MDR report key: 1760786 · Received July 7, 2010

    Report

    Report Number
    1530449-2010-00100
    Event Type
    Other
    Date Received
    July 7, 2010
    Report Date
    June 9, 2010
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING 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. FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GUM 20%) CREAM 1APPLIC.

    Description of Event or Problem · 1

    WAS NOT ABLE TO WALK, COULDN'T WALK [ABASIA]. HAS NOT WALKED VERY WELL IN TWO YEARS [GAIT DISTURBANCE]. CRYING IN PAIN. CASE DESCRIPTION: A CONSUMER REPORTED THAT HER DAUGHTER USED FIXODENT DENTURE ADHESIVE, (VERSION UNKNOWN) CREAM AND POLIDENT AFTER KNOCKING OUT HER TWO FRONT TEETH. AFTER ONE OR TWO MONTHS OF PRODUCT USE SHE WAS CRYING IN PAIN AND WAS NOT ABLE TO WALK. SHE HAS NOT WALKED VERY WELL IN TWO YEARS, AND SHE'S IN A WALKER. A PHYSICIAN WAS VISITED. HER DAUGHTER HAD UNSPECIFIED TESTING AND "IT DIDN'T COME OUT IN THE TESTS" (ZINC). THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - KNOCKED OUT 2 FRONT TEETH. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Disability