BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2034661 · Received March 17, 2011

    Report

    Report Number
    1530449-2011-00061
    Event Type
    Other
    Date Received
    March 17, 2011
    Report Date
    February 15, 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 WAS NOT PROVIDED BY THE REPORTER, THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    PERIPHERAL NEUROPATHIES IN HANDS AND FEET [NEUROPATHY PERIPHERAL], USES A WALKER [GAIT DISTURBANCE]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, AN ELDERLY FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, ORIGINAL CREAM DAILY BEGINNING (B)(6) 2011 AFTER USING POLYGRIP DENTURE ADHESIVE ON HER DENTURES DAILY BEGINNING 2008 THROUGH (B)(6) 2011, AND REPORTED THE FOLLOWING: PERIPHERAL NEUROPATHIES IN HANDS AND FEET, NOW USES A WALKER. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER FOR THE PAST 3 YEARS, DIABETES, HAD A STROKE 5 YEARS AGO. NO FURTHER INFO 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 NONE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other