BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE

    MDR report key: 1669182 · Received April 27, 2010

    Report

    Report Number
    1530449-2010-00068
    Event Type
    Other
    Date Received
    April 27, 2010
    Report Date
    March 29, 2010
    Manufacturer
    PROCTER & GAMBLE MFG CO.
    Product Code
    KOO
    PMA / PMN Number
    K9452000
    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

    PROBLEM WALKING [GAIT DISTURBANCE]. PROBLEM BALANCING [BALANCE DISORDER]. DEVICE INEFFECTIVE (FIXODENT DOESN'T LAST LONG) [DEVICE INEFFECTIVE]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, A MALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM 1 APPLIC, SEVERAL TIMES A DAY, FOR A WHILE NOW AND REPORTED THE FOLLOWING: PROBLEM WALKING, PROBLEM BALANCING, DEVICE INEFFECTIVE (FIXODENT DOESN'T LAST LONG). A HEALTH CARE PROFESSIONAL WAS VISITED. LAB TESTS INCLUDED BLOOD COPPER AND BLOOD ZINC WITH RESULTS OF "WITHIN REASONABLE LIMITS". TREATMENT: USED CANE, NOW USES WALKER TO GET AROUND. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: ALLERGY - NONE REPORTED, MEDICAL HISTORY - DENTURE WEARER. CONCOMITANT MEDICATIONS NOT SPECIFIED. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Disability