BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2093683 · Received April 21, 2011

    Report

    Report Number
    1530449-2011-00078
    Event Type
    Other
    Date Received
    April 21, 2011
    Report Date
    March 31, 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]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. BURNING IN HANDS, ARMS, FEET AND LEGS [BURNING SENSATION]. TINGLING IN HANDS, ARMS, FEET AND LEGS [PARESTHESIA]. NUMBNESS IN FINGERTIPS, HANDS, ARMS, FEET AND LEGS [HYPOAESTHESIA]. PAIN IN HANDS, ARMS, FEET AND LEGS [PAIN IN EXTREMITY]. WEAKNESS IN HANDS, ARMS, FEET AND LEGS [MUSCULAR WEAKNESS]. LOSS OF CONTROL IN HANDS, ARMS, FEET AND LEGS [MOTOR DYSFUNCTION]. SPASMS IN HANDS, ARMS, FEET AND LEGS [MUSCLE SPASMS]. UNSTEADY WALKING OR STANDING CAUSING TO STUMBLE OR FALL [GAIT DISTURBANCE]. LOSS OF ENERGY [ASTHENIA]. NUMBNESS IN TONGUE [HYPOAESTHESIA ORAL]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HIS CLIENT, A (B)(6) MALE, USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN AND SUPER POLIGRIP FROM 1990 TO PRESENT AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, ZINC TOXICITY, EXTENSIVE NERVE DAMAGE, BURNING IN HANDS, ARMS, FEET AND LEGS, TINGLING IN HANDS, ARMS, FEET AND LEGS, NUMBNESS IN FINGERTIPS, HANDS, ARMS, FEET AND LEGS, PAIN IN HANDS, ARMS, FEET AND LEGS, WEAKNESS IN HANDS, ARMS, FEET AND LEGS, LOSS OF CONTROL IN HANDS, ARMS, FEET AND LEGS, SPASMS IN HANDS, ARMS, FEET AND LEGS, UNSTEADY WALKING OR STANDING, CAUSING A STUMBLE OR FALL, LOSS OF ENERGY, NUMBNESS IN TONGUE. 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 UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability