BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2163556 · Received June 9, 2011

    Report

    Report Number
    1530449-2011-00102
    Event Type
    Other
    Date Received
    June 9, 2011
    Report Date
    May 20, 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]. HYPOCUPREMIA [COPPER DEFICIENCY]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. TINGLING IN FEET, TOES, LEGS, FINGERS, HANDS, AND ARMS [PARAESTHESIA]. NUMBNESS IN FEET, TOES, LEGS, FINGERS, HANDS, AND ARMS [HYPOAESTHESIA]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR ELDERLY MALE CLIENT, NOW AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM, UNSPECIFIED TOTAL DAILY USE BEGINNING 2002 THROUGH 2004, AND/OR SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM, UNSPECIFIED TOTAL DAILY USE BEGINNING 2002 TO PRESENT, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, HYPOCUPREMIA, AND EXTENSIVE NERVE DAMAGE RESULTING IN TINGLING IN FEET, TOES, LEGS, FINGERS, HANDS, AND ARMS, AND NUMBNESS IN FEET, TOES, LEGS, FINGERS, HANDS, AND ARMS. 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 65 YR Disability