BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE

    MDR report key: 2020323 · Received March 14, 2011

    Report

    Report Number
    1530449-2011-00047
    Event Type
    Other
    Date Received
    March 14, 2011
    Report Date
    February 15, 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]. LOSS OF BALANCE [BALANCE DISORDER]. TINGLING IN HANDS, ARMS FEET AND LEGS [PARAESTHESIA]. NUMBNESS IN HANDS, ARMS, FEET AND LEGS [HYPOAESTHESIA]. BURNING IN HANDS, ARMS, FEET AND LEGS [BURNING SENSATION]. PAIN IN HANDS, ARMS, FEET, AND LEGS; UNEXPLAINED PAIN IN THE EXTREMITIES [PAIN IN EXTREMITY]. WEAKNESS IN HANDS, ARMS, FEET AND LEGS [MUSCULAR WEAKNESS]. NAUSEA [NAUSEA]. DIZZINESS [DIZZINESS]. DIFFICULTY STANDING [DYSSTASIA]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, A (B)(6) FEMALE, USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM AND SUPER POLIGRIP DENTURE ADHESIVE FROM 2005 THROUGH (B)(6)-2010 AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, HYPOCUPREMIA, EXTENSIVE NERVE DAMAGE, LOSS OF BALANCE, TINGLING IN HANDS, ARMS, FEET AND LEGS, NUMBNESS IN HANDS, ARMS, FEET AND LEGS, BURNING IN HANDS, ARMS, FEET AND LEGS, PAIN IN HANDS, ARMS, FEET, AND LEGS; UNEXPLAINED PAIN IN THE EXTREMITIES, WEAKNESS IN HANDS, ARMS, FEET AND LEGS, NAUSEA, UNEXPLAINED PAIN IN THE EXTREMITIES, DIZZINESS, DIFFICULTY STANDING. TREATMENT: MEDICAL CARE AND TREATMENT. 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 UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability