BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33 PERCENT CEL

    MDR report key: 1971922 · Received January 24, 2011

    Report

    Report Number
    1530449-2011-00010
    Event Type
    Other
    Date Received
    January 24, 2011
    Report Date
    January 4, 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], EXTENSIVE NERVE DAMAGE [NERVE INJURY], PERIPHERAL NEUROPATHY [NEUROPATHY PERIPHERAL], ZINC TOXICITY [METAL POISONING[, BURNING OF UPPER AND LOWER EXTREMITIES [BURNING SENSATION], NUMBNESS OF UPPER AND LOWER EXTREMITIES [HYPOAESTHESIA], TINGLING IN UPPER AND LOWER EXTREMITIES [PARAESTHESIA]. AN ATTORNEY REPORTED THAT THEIR ADULT FEMALE CLIENT, NOW AGE (B)(6) YEARS, USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM BEGINNING (B)(6) 2010 THROUGH (B)(6) 2010 AFTER USING SUPER POLIGRIP DENTURE ADHESIVE CREAM, UNSPECIFIED TOTAL DAILY USE BEGINNING 1996 THROUGH 2010, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, ZINC TOXICITY AND EXTENSIVE NERVE DAMAGE THAT RESULTED IN SYMPTOMS TO INCLUDE BURNING OF UPPER AND LOWER EXTREMITIES, NUMBNESS OF UPPER AND LOWER EXTREMITIES AND TINGLING IN UPPER AND LOWER EXTREMITIES, AND PERIPHERAL NEUROPATHY. TREATMENT: HAS RECEIVED AND WILL CONTINUE TO RECEIVE 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 UNK (CALCIUM ZINC GANTREZ SALT 33 PERCENT CEL NONE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability