BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2020317 · Received March 14, 2011

    Report

    Report Number
    1530449-2011-00050
    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 RPTR THEREFORE UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    NEUROLOGIC DISEASE; PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. HYPOCUPREMIA [COPPER DEFICIENCY]. WEAKNESS OF LEGS [MUSCULAR WEAKNESS]. DIZZINESS [DIZZINESS]. BURNING SENSATION IN FEET [BURNING SENSATION]. PAIN IN LEGS [PAIN IN EXTREMITY]. LOSS OF BALANCE [BALANCE DISORDER]. ANEMIA [ANEMIA]. NUMBNESS IN FEED [HYPOAESTHESIA]. TINGLING IN FEET [PARESTHESIA]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR ELDERLY MALE CLIENT, NOW AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM AND/OR SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM, UNSPECIFIED TOTAL DAILY USES BEGINNING (B)(6) 2007 THROUGH (B)(6) 2009, AND REPORTED THE FOLLOWING: NEUROLOGIC DISEASE; PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, HYPOCUPREMIA, LOSS OF BALANCE, DIZZINESS, ANEMIA, WEAKNESS IN LEGS, PAIN IN LEGS BURNING SENSATION IN FEET, NUMBNESS IN FEET, AND TINGLING IN FEET. TREATMENT: HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED 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 UNKNOWN (CALCIUM ZINC GANTREZ SALT 33 %, CELL NONE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Disability