BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, COMPLETE MULTICARE (CALCIUM ZINC GANTREZ SALT 33%, CE

    MDR report key: 2020298 · Received March 14, 2011

    Report

    Report Number
    1530449-2011-00053
    Event Type
    Other
    Date Received
    March 14, 2011
    Report Date
    February 11, 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

    USES A WALKER OUTSIDE, BECAUSE OF BALANCE [BALANCE DISORDER]. NEUROPATHY [NEUROPATHY PERIPHERAL]. NUMBNESS IN FINGERS, HANDS, ARMS, ANKLES [HYPOAESTHESIA]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, AN ADULT FEMALE AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, COMPLETE MULTICARE CREAM 1 APPLIC, 1/DAY AND REPORTED THE FOLLOWING: NEUROPATHY, NUMBNESS IN FINGERS, HANDS, ARMS, AND ANKLES. THE CONSUMER HAS VISITED HER PHYSICIAN. TREATMENT: NONE. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFO WAS PROVIDED. ON (B)(6)-2011 UPDATE: DETAILS REVEALED IN A REVIEW OF THE INITIAL CONTACT OF (B)(6)-2011: THE CONSUMER REPORTED THAT SHE USED FIXODENT ONCE DAILY IN THE MORNING FOR A LONG TIME TO HOLD HER OLD BRIDGE BUT HAS A NEW BRIDGE NOW AND NO LONGER NEEDS FIXODENT. SHE HAS HAD NUMBNESS IN HER FINGERS, HANDS, FEET, KIND OF UP INTO HER ANKLES AND RECENTLY GRADUATED FROM RELIGIOUS USE OF A CANE TO NOW USING A WALKER FOR BALANCE WHEN SHE IS OUTSIDE OF HER HOUSE. PAST MEDICAL HISTORY INCLUDED: ALLERGY - NO ALLERGIES, MEDICAL HISTORY - A LITTLE HARD OF HEARING, HAS A BRIDGE. CONCOMITANT MEDICATION INCLUDED: "NO MEDICATION". NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability