BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1943601 · Received December 13, 2010

    Report

    Report Number
    1530449-2010-00135
    Event Type
    Other
    Date Received
    December 13, 2010
    Report Date
    November 29, 2010
    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]. NERVE DAMAGE [NERVE INJURY].SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. ZINC TOXICITY [METAL POISONING]. LEG WEAKNESS [MUSCULAR WEAKNESS]. DIFFICULTY WALKING THAT NECESSITATES THE USE OF A WALKER [GAIT DISTURBANCE]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HER (B)(6) MALE CLIENT USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM BEGINNING IN 2007 THROUGH (B)(6) 2010 AFTER USING SUPER POLIGRIP BEGINNING IN 2005 THROUGH 2007, AND REPORTED THE FOLLOWING PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, NERVE DAMAGE, SEVERE AND PERMANENT PHYSICAL INJURIES, ZINC TOXICITY, LEG WEAKNESS, AND DIFFICULTY WALKING THAT NECESSITIES THE USE OF A WALKER. HEALTH CARE PROFESSIONAL WAS VISITED. TREATMENT: MEDICAL CARE AND TREATMENT AND USES A WALKER. 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 MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Disability