BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU

    MDR report key: 1912758 · Received November 2, 2010

    Report

    Report Number
    1530449-2010-00123
    Event Type
    Other
    Date Received
    November 2, 2010
    Report Date
    October 15, 2010
    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 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]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. NEUROPATHY [NEUROPATHY PERIPHERAL]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. HYPOCUPREMIA [COPPER DEFICIENCY]. TINGLING LEGS [PARAESTHESIA]. TWITCHING LEGS [MUSCLE TWITCHING]. INVOLUNTARY MOVEMENT IN LEGS [DYSKINESIA]. HAND TREMORS [TREMOR]. BALANCE PROBLEMS [BALANCE DISORDER]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, A (B)(6) MALE, USED FIXODENT DENTURE ADHESIVE, VERSION UNK, CREAM BEGINNING IN 1972 THROUGH 1988 AND SUPER POLIGRIP BEGINNING IN 1988 THROUGH 2009, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, EXTENSIVE NERVE DAMAGE, NEUROPATHY, SEVERE AND PERMANENT PHYSICAL INJURIES, HYPOCUPREMIA, TINGLING LEGS, TWITCHING LEGS, INVOLUNTARY MOVEMENT IN LEGS, HAND TREMORS, AND BALANCE PROBLEMS. HEALTH CARE PROFESSIONAL WAS VISITED. TREATMENT: "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 UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability