BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1884154 · Received October 14, 2010

    Report

    Report Number
    1530449-2010-00119
    Event Type
    Other
    Date Received
    October 14, 2010
    Report Date
    September 17, 2010
    Manufacturer
    PROCTER & GAMBLE MFG. 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 PROD TESTING.

    Description of Event or Problem · 1

    PROFOUND AND PERMANENT NEUROLOGICAL INJURIES (NERVOUS SYSTEM DISORDER), SEVERE AND PERMANENT PHYSICAL INJURIES (INJURY), DIFFICULTY WALKING (GAIT DISTURBANCE), NUMBNESS IN FACE (HYPOAESTHESIA FACIAL), TINGLING IN FACE (PARAESTHESIA), NUMBNESS HANDS, ARMS, AND LEGS (HYPOAESTHESIA), TINGLING HANDS, ARMS, AND LEGS (PARAESTHESIA), HEADACHES (HEADACHE), DIZZINESS (DIZZINESS), HYPOCUPREMIA (COPPER DEFICIENCY), ANEMIA (ANAEMIA), NEUROLOGICAL DAMAGE (NERVE INJURY). CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HER CLIENT, A (B)(6) FEMALE, USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM FROM 1997 THROUGH (B)(6) 2010 AND SUPER POLIGRIP DENTURE ADHESIVE CREAM FROM 1997 TO PRESENT AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, HYPOCUPREMIA RESULTING IN NEUROLOGICAL DAMAGE WITH SYMPTOMS OF DIFFICULTY WALKING, NUMBNESS AND TINGLING IN HANDS, ARMS, FACE AND LEGS, HEADACHES, DIZZINESS, AND ANEMIA. A HEALTH CARE PROFESSIONAL WAS VISITED. TREATMENT: 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%, CELLU DENTURE ADHESIVE KOO PROCTER & GAMBLE MFG. CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability