BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2020324 · Received March 14, 2011

    Report

    Report Number
    1530449-2011-00051
    Event Type
    Other
    Date Received
    March 14, 2011
    Report Date
    February 15, 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]. TINGLING IN FEET AND LEGS [PARAESTHESIA]. BURNING IN FEET AND LEGS [BURNING SENSATION]. WEAKNESS IN FEET AND LEGS [MUSCULAR WEAKNESS]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. UNSTEADY WALKING OR STANDING [BALANCE DISORDER]. NUMBNESS IN FEET AND LEGS [HYPOAESTHESIA]. PAIN IN FEET AND LEGS [PAIN IN EXTREMITY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR ADULT MALE CLIENT, NOW AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM AND/OR SUPER POLIGRIP DENTURE ADHESIVE CREAM, UNSPECIFIED TOTAL DAILY USES BEGINNING 1995 TO PRESENT, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, ZINC TOXICITY, EXTENSIVE NERVE DAMAGE RESULTING IN UNSTEADY WALKING OR STANDING, TINGLING IN FEET AND LEGS, NUMBNESS IN FEET AND LEGS, BURNING IN FEET AND LEGS, PAIN IN FEET AND LEGS, AND WEAKNESS IN FEET AND LEGS. TREATMENT: HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. 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, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33% CELLULOSE DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability