BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2099534 · Received May 13, 2011

    Report

    Report Number
    1530449-2011-00088
    Event Type
    Other
    Date Received
    May 13, 2011
    Report Date
    April 18, 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

    CAN'T WALK AND USING A CANE [GAIT DISTURBANCE]. LIMPING [GAIT DISTURBANCE]. MADE LEG WEAK [MUSCULAR WEAKNESS]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, A MALE AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, ORIGINAL CREAM, UNSPECIFIED TOTAL DAILY USE (BUT MENTIONED THAT HE WAS USING A LOT OF THE PRODUCT) BEGINNING (B)(6) 2011, AND ALL OF A SUDDEN CAN'T WALK AND IS USING A CANE; HE IS LIMPING AND HIS LEG IS WEAK. HE IS CONSTANTLY VISITING HIS PHYSICIAN WHO HAS SAID THAT HE HAS TO GET SOME TYPE OF EXERCISE BECAUSE FIXODENT MADE HIS LEG WEAK. THE CONSUMER HAS DISCONTINUED USING FIXODENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: ALLERGY - "NO ALLERGIES". CONCOMITANT MEDICATION INCLUDED: ANTIHYPERTENSIVES AND DRUG USED IN DIABETES. 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 MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability DRUG USED IN DIABETES| ANTIHYPERTENSIVES