BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1971921 · Received January 24, 2011

    Report

    Report Number
    1530449-2011-00015
    Event Type
    Other
    Date Received
    January 24, 2011
    Report Date
    January 14, 2011
    Manufacturer
    PROCTER & GAMBLE MFG 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]. PAIN [PAIN]. MUSCLE CRAMPING [MUSCLE SPASMS]. TINGLING IN HANDS AND FEET [PARAESTHESIA]. NUMBNESS IN HANDS AND FEET [HYPOAESTHESIA]. LOSS OF BALANCE [BALANCE DISORDER]. DIFFICULTY WALKING [GAIT DISTURBANCE]. ZINC TOXICITY [METAL POISONING]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. LACK OF COORDINATION [COORDINATION ABNORMAL]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT A (B)(6) FEMALE USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM BEGINNING IN 2003, AFTER USING SUPER POLIGRIP ORIGINAL BEGINNING IN 1987 THROUGH 2003, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, PAIN, MUSCLE CRAMPING, TINGLING IN HANDS AND FEET, NUMBNESS IN HANDS AND FEET, LOSS OF BALANCE, DIFFICULTY WALKING, ZINC TOXICITY, EXTENSIVE NERVE DAMAGE, LACK OF COORDINATION, AND SEVERE AND PERMANENT PHYSICAL INJURIES. HEALTH CARE PROFESSIONAL WAS VISITED. TREATMENT: UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFO 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 MFG CO

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability