BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2001151 · Received February 18, 2011

    Report

    Report Number
    1530449-2011-00026
    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]. PAIN ALL OVER [PAIN]. TINGLING [PARAESTHESIA]. NUMBNESS [HYPOAESTHESIA]. WEAKNESS [ASTHENIA]. LOSS OF MUSCLE CONTROL [MOTOR DYSFUNCTION]. ZINC TOXICITY [METAL POISONING]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. DIZZINESS [DIZZINESS]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR ELDERLY FEMALE CLIENT, NOW AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM CONCURRENTLY WITH SUPER POLIGRIP DENTURE ADHESIVE CREAM, UNSPECIFIED TOTAL DAILY USES BEGINNING (B)(6)-2010 THROUGH (B)(6) 2010, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, ZINC TOXICITY, EXTENSIVE NERVE DAMAGE RESULTING IN PAIN ALL OVER HER BODY, TINGLING, NUMBNESS, WEAKNESS, DIZZINESS, AND LOSS OF MUSCLE CONTROL, SEVERE AND PERMANENT PHYSICAL INJURIES. 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 UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Disability