BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2163557 · Received June 9, 2011

    Report

    Report Number
    1530449-2011-00101
    Event Type
    Other
    Date Received
    June 9, 2011
    Report Date
    May 19, 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
    OTHER

    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

    PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. ZINC TOXICITY [METAL POISONING]. COPPER DEFICIENCY [COPPER DEFICIENCY]. PAIN IN LEGS [PAIN IN EXTREMITY]. BURNING SENSATION IN FEET [BURNING SENSATION]. NUMBNESS IN FEET [HYPOAESTHESIA]. DIZZINESS [DIZZINESS]. LOSS OF BALANCE [BALANCE DISORDER]. WEAKNESS IN LEGS [MUSCULAR WEAKNESS]. TINGLING FEET [PARAESTHESIA]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR (B)(6) FEMALE CLIENT USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM 1 APPLIC, UNSPECIFIED FREQUENCY BEGINNING IN 1973 THROUGH 2010 AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, ZINC TOXICITY, COPPER DEFICIENCY, PAIN IN LEGS, BURNING SENSATION IN FEET, NUMBNESS IN FEET, DIZZINESS, LOSS OF BALANCE, WEAKNESS IN LEGS, AND TINGLING FEET. HEALTH CARE PROFESSIONAL WAS VISITED. TREATMENT: UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION 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 MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability