BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2093692 · Received April 21, 2011

    Report

    Report Number
    1530449-2011-00076
    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]. TINGLING HANDS, ARMS, FEET, LEGS [PARESTHESIA]. BURNING IN HANDS, ARMS, FEET, LEGS [BURNING SENSATION]. UNSTEADY WALKING STANDING [BALANCE DISORDER]. LOSS OF CONTROL IN HANDS, ARMS, FEET, LEGS [MOTOR DYSFUNCTION]. PAIN IN HANDS, ARMS, FEET, LEGS [PAIN IN EXTREMITY]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. NUMBNESS IN HANDS, ARMS, FEET, LEGS [HYPOAESTHESIA]. SPASMS IN HANDS, ARMS, FEET, LEGS [MUSCLE SPASMS]. DIZZY, LIGHTHEADED [DIZZINESS]. STUMBLING [GAIT DISTURBANCE]. FREQUENT HEADACHES [HEADACHE]. SHOULDER ACHING [MUSCULOSKELETAL PAIN]. STOMACH PAIN [ABDOMINAL PAIN UPPER]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR FEMALE CLIENT, AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM 1 APPLIC, UNSPECIFIED FREQUENCY BEGINNING (B)(6) 2008, AFTER USING SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM 1 APPLIC, UNSPECIFIED FREQUENCY BEGINNING (B)(6) 2008, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, ZINC TOXICITY, TINGLING HANDS, ARMS, FEET, LEGS, BURNING IN HANDS, ARMS, FEET, LEGS, UNSTEADY WALKING STANDING, LOSS OF CONTROL IN HANDS, ARMS, FEET, LEGS, PAIN IN HANDS, ARMS, FEET, LEGS, EXTENSIVE NERVE DAMAGE, NUMBNESS IN HANDS, ARMS, FEET, LEGS, SPASMS IN HANDS, ARMS, FEET, LEGS, DIZZY, LIGHTHEADED, STUMBLING, FREQUENT HEADACHES, SHOULDER ACHING, AND STOMACH PAIN. 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 47 YR Disability