BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2001137 · Received February 18, 2011

    Report

    Report Number
    1530449-2011-00031
    Event Type
    Other
    Date Received
    February 18, 2011
    Report Date
    February 7, 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]. TINGLING IN FEET, LEGS, ARMS AND HANDS [PARAESTHESIA]. NUMBNESS IN FEET, LEGS, ARMS AND HANDS [HYPOAESTHESIA]. BURNING IN FEET, LEGS, ARMS AND HANDS [BURNING SENSATION]. PAIN IN FEET, LEGS, ARMS AND HANDS [PAIN IN EXTREMITY]. WEAKNESS IN FEET, LEGS, ARMS AND HANDS [MUSCULAR WEAKNESS]. ZINC TOXICITY [METAL POISONING]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. LOSS OF BALANCE [BALANCE DISORDER]. FATIGUE [FATIGUE]. DIZZINESS [DIZZINESS]. UNSTEADY STANDING [DYSSTASIA]. UNSTEADY WALKING [GAIT DISTURBANCE]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HER (B)(6) FEMALE CLIENT USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM FROM (B)(6) 2000 THROUGH (B)(6) 2010 AND SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM FROM 1979 THROUGH (B)(6) 2010, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, TINGLING IN FEET, LEGS, ARMS AND HANDS, NUMBNESS IN FEET, LEGS, ARMS AND HANDS, BURNING IN FEET, LEGS, ARMS AND HANDS, PAIN IN FEET, LEGS, ARMS AND HANDS, WEAKNESS IN FEET, LEGS, ARMS AND HANDS, ZINC TOXICITY, EXTENSIVE NERVE DAMAGE, LOSS OF BALANCE, FATIGUE, DIZZINESS, UNSTEADY STANDING, UNSTEADY WALKING, SEVERE AND PERMANENT PHYSICAL INJURIES. 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 NONE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability