BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2020304 · Received March 14, 2011

    Report

    Report Number
    1530449-2011-00048
    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

    PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. ZINC TOXICITY [METAL POISONING]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. LOSS OF BALANCE [BALANCE DISORDER]. NAUSEA [NAUSEA]. NUMBNESS IN HANDS, LEGS, FEET, AND SHOULDER [HYPOAESTHESIA]. TINGLING IN HANDS, LEGS, FEET, AND SHOULDER [PARESTHESIA]. CASE DESCRIPTION; A CONSUMER REPORTED THAT THEY, A FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM AND SUPER POLIGRIP DENTURE ADHESIVE, BOTH BEGINNING IN 2004 THROUGH (B)(6) 2010 AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, ZINC TOXICITY, EXTENSIVE NERVE DAMAGE, LOSS OF BALANCE, NAUSEA, NUMBNESS IN HAND, LEGS, FEET, AND SHOULDER, AND TINGLING IN HANDS, LEGS, FEET, AND SHOULDER. HEALTH CARE PROFESSIONAL WAS VISITED. 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 UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Disability