BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2001136 · Received February 18, 2011

    Report

    Report Number
    1530449-2011-00035
    Event Type
    Other
    Date Received
    February 18, 2011
    Report Date
    February 12, 2011
    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 NOT PROVIDED, THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    NERVE PROBLEMS IN BACK AND ONE OF LEGS [NERVOUS SYSTEM DISORDER]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, A MALE AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, ORIGINAL CREAM 1 APPLIC ON HIS UPPER PLATE, 1/DAY FOR YEARS AND REPORTED THE FOLLOWING: NERVE PROBLEMS IN HIS BACK AND ONE OF HIS LEGS. THE CONSUMER VISITED HIS PHYSICIAN. TREATMENT: AN OPERATION ON HIS BACK RELATED TO HIS SYMPTOMS 1.5 YEARS AGO. THE CASE OUTCOME WAS UNKNOWN. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - HAS AN UPPER PLATE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, ORIGINAL (CALCUIM ZINC GANTREZ SALT 33%, CELLULOSE GU NONE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other