BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1993313 · Received February 4, 2011

    Report

    Report Number
    1530449-2011-00018
    Event Type
    Other
    Date Received
    February 4, 2011
    Report Date
    January 26, 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]. ZINC TOXICITY [METAL POISONING]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. PAIN IN LEGS, FEET, HANDS, AND ARMS [PAIN IN EXTREMITY]. NUMBNESS IN LEGS AND FEET [HYPOAESTHESIA]. GASTROINTESTINAL PROBLEMS [GASTROINTESTINAL DISORDER]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT A (B)(6) MALE CLIENT USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM AND SUPER POLIGRIP ORIGINAL, BOTH BEGINNING IN 1996, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, ZINC TOXICITY, EXTENSIVE NERVE DAMAGE, PAIN IN LEGS, FEET, HANDS, AND ARMS, NUMBNESS IN LEGS AND FEET, GASTROINTESTINAL PROBLEMS, AND 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 INFO WAS REPORTED.

    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 50 YR Disability