BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1971927 · Received January 24, 2011

    Report

    Report Number
    1530449-2011-00012
    Event Type
    Other
    Date Received
    January 24, 2011
    Report Date
    December 28, 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 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]. NERVE DAMAGE [NERVE INJURY]. NEUROPATHY IN FEET [NEUROPATHY PERIPHERAL]. ZINC TOXICITY [METAL POISONING]. TINGLING IN UPPER AND LOWER EXTREMITIES [PARAESTHESIA]. SPASMS IN UPPER AND LOWER EXTREMITIES [MUSCLE SPASMS]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR ADULT CLIENT, NOW AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM CONCURRENTLY WITH SUPER POLIGRIP DENTURE ADHESIVE CREAM, UNSPECIFIED TOTAL DAILY USES BEGINNING IN 1986 TO PRESENT, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, NERVE DAMAGE, NEUROPATHY IN FEET, ZINC TOXICITY, TINGLING AND SPASMS IN UPPER AND LOWER EXTREMITIES. TREATMENT: HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NO 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 52 YR Disability