BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, ORIGINAL (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GU

    MDR report key: 1651947 · Received April 5, 2010

    Report

    Report Number
    1530449-2010-00059
    Event Type
    Other
    Date Received
    April 5, 2010
    Report Date
    November 16, 2009
    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. ADD'L INFO - (US) OTC DEVICE.

    Description of Event or Problem · 1

    NERVE DAMAGE [NERVE INJURY]; NUMBNESS IN HANDS, FINGER, ARMS, FEET AND LEGS [HYPOAESTHESIA]; CRAMPING IN HANDS, FINGERS, ARMS, FEET AND LEGS [MUSCLE SPASMS]; TINGLING IN HANDS, FINGERS, ARMS, FEET AND LEGS [PARAESTHESIA]; PAIN IN HANDS, FINGERS, ARMS, FEET AND LEGS [PAIN IN EXTREMITY]; MEMORY LOSS [AMNESIA]; NO INTEREST IN SEXUAL ACTIVITIES [LIBIDO DECREASED]. CASE DESCRIPTION: A REGULATORY AUTHORITY REP REPORTED THAT THEY WERE NOTIFIED THAT AN ADULT CONSUMER, AGE AND GENDER UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, ORIGINAL CREAM 1 APPLICATION 3-4 TIMES A WEEK TO SECURE THEIR DENTURES (B)(6) IN 1996 THROUGH 2009 AND REPORTED THE FOLLOWING; NERVE DAMAGE, NUMBNESS, CRAMPING, TINGLING AND PAIN IN THE HANDS, FINGERS, ARMS, FEET AND LEGS. THE CONSUMER ALSO REPORTED MEMORY LOSS AND NO INTEREST IN SEXUAL ACTIVITIES. THE CONSUMER RECEIVED UNSPECIFIED MEDICAL CARE AND TREATMENT, INCLUDING TWO SURGERIES ON LEFT ARM TO REARRANGE THE NERVES. THE SURGERIES PROVIDED NO RELIEF. THE CONSUMER WAS WAITING ON TEST RESULTS OF COPPER AND ZINC LEVELS. 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, ORIGINAL (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GU DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention