BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2011920 · Received February 25, 2011

    Report

    Report Number
    1530449-2011-00039
    Event Type
    Other
    Date Received
    February 25, 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]. TINGLING IN HANDS, ARMS, FEET AND LEGS [PARAESTHESIA]. BURNING IN HANDS, ARMS, FEET AND LEGS [BURNING SENSATION]. PAIN IN HANDS, ARMS, FEET AND LEGS [PAIN IN EXTREMITY]. WEAKNESS IN HANDS, ARMS, FEET AND LEGS [MUSCULAR WEAKNESS]. DIZZINESS/LIGHTHEADEDNESS [DIZZINESS]. UNSTEADINESS WHEN STANDING [BALANCE DISORDER]. ZINC TOXICITY [METAL POISONING]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. MUSCLE ACHES [MYALGIA]. UNSTEADINESS WHEN WALKING [GAIT DISTURBANCE]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR ADULT FEMALE CLIENT, NOW (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM, UNSPECIFIED TOTAL DAILY USE BEGINNING (B)(6)-1990 THROUGH (B)(6)-2010 AND SUPER POLIGRIP DENTURE ADHESIVE CREAM, UNSPECIFIED TOTAL DAILY USE BEGINNING (B)(6)-2000 TO PRESENT, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, ZINC TOXICITY, EXTENSIVE NERVE DAMAGE RESULTING IN TINGLING IN HANDS, ARM, FEET AND LEGS, BURNING IN HANDS, ARM, FEET AND LEGS, PAIN AND WEAKNESS IN HANDS, ARMS, FEET AND LEGS, DIZZINESS/LIGHTHEADEDNESS, MUSCLE ACHES, AND UNSTEADINESS WHEN WALKING AND STANDING, 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 UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability