BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2859866 · Received December 4, 2012

    Report

    Report Number
    1530449-2012-00088
    Event Type
    Other
    Date Received
    December 4, 2012
    Report Date
    November 8, 2012
    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 AND CASE CONCERNS LONG-TERM PRODUCT USE.

    Description of Event or Problem · 1

    BEGAN TO HAVE TROUBLE WALKING IN THE LAST FEW MONTHS AND NOW CANNOT WALK AT ALL [ABASIA]. NUMBNESS FEET, LEGS AND HANDS [HYPOAESTHESIA]. ZINC LEVELS ELEVATED [BLOOD ZINC INCREASED]. COPPER LEVELS DESTROYED [COPPER DEFICIENCY]. HAVE NO USE OF HANDS [MOTOR DYSFUNCTION]. TOXIC LEVEL OF ZINC IN BODY [METAL POISONING]. USED FIXODENT TWICE A DAY [DEVICE MISUSE]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, A FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, ORIGINAL CREAM 1 APPLIC, 2 /DAY AND FOR THE PAST 46 YEARS AND ALSO FIXODENT DENTURE ADHESIVE, VERSION UNK POWDER AND REPORTED THE FOLLOWING: BEGAN TO HAVE TROUBLE WALKING IN THE LAST FEW MONTHS AND NOW CANNOT WALK AT ALL, NUMBNESS FEET, LEGS AND HANDS, AND SHE HAS NO USE OF HER HANDS. SHE VISITED A PHYSICIAN, STATED HER ZINC LEVELS WERE ELEVATED, SHE HAD A TOXIC LEVELS OF ZINC, AND HER COPPER LEVELS WERE DESTROYED. TREATMENT: VITAMINS, SUPPLEMENTS, WITH AND TUBE FEEDINGS. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. 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 DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability