BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33 PERCENT CEL

    MDR report key: 2170207 · Received July 5, 2011

    Report

    Report Number
    1530449-2011-00113
    Event Type
    Other
    Date Received
    July 5, 2011
    Report Date
    June 14, 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], HYPOCUPREMIA [COPPER DEFICIENCY], EXTENSIVE NERVE DAMAGE [NERVE INJURY], SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY], TINGLING IN LEGS, FEET, AND HANDS [PARAESTHESIA], NUMBNESS IN LEGS, FEET, AND HANDS [HYPOAESTHESIA], WEAKNESS IN LEGS, FEET, AND HANDS [MUSCULAR WEAKNESS], PAIN IN LEGS, FEET, AND HANDS [PAIN IN EXTREMITY], LOSS OF BALANCE [BALANCE DISORDER], METALLIC TASTE IN MOUTH [DYSGEUSIA]. AN ATTORNEY REPORTED THAT THEIR ELDERLY MALE CLIENT, NOW AGE (B)(6) YEARS, USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM, UNSPECIFIED TOTAL DAILY USE BEGINNING 1990 THROUGH APRIL 2011 CONCURRENTLY WITH SUPER POLIGRIP, UNSPECIFIED TOTAL DAILY USE BEGINNING 1990 TO PRESENT, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, HYPOCUPREMIA AND EXTENSIVE NERVE DAMAGE RESULTING IN TINGLING IN LEGS, FEET, AND HANDS, NUMBNESS IN LEGS, FEET AND HANDS, WEAKNESS IN LEGS, FEET, AND HANDS, PAIN IN LEGS, FEET, AND HANDS, LOSS OF BALANCE, AND METALLIC TASTE IN MOUTH. TREATMENT: HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. DOSE, FREQUENCY AND ROUTE USED: UNK, INTRAORAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Disability