BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1651932 · Received April 5, 2010

    Report

    Report Number
    1530449-2010-00020
    Event Type
    Other
    Date Received
    April 5, 2010
    Report Date
    November 23, 2009
    Manufacturer
    PROCTER & GAMBLE MFG CO.
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    NEUROPATHY [NEUROPATHY PERIPHERAL], COULD NOT WALK WITHOUT FALLING, USES A CANE [GAIT DISTURBANCE], NUMBNESS IN EXTREMITIES [HYPOAESTHESIA], TINGLING IN EXTREMITIES [PARAESTHESIA], ANEMIA [ANAEMIA]. CASE DESCRIPTION: A REP OF A REGULATORY AUTHORITY REPORTED THAT A CONSUMER, AN ADULT AGE GENDER UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM CONCURRENTLY WITH POLIGRIP AND SEA BOND 1 APPLIC, ONE/DAY (B)(6) IN 1982 THROUGH 2009 AND REPORTED THE FOLLOWING: COULD NOT WALK WITHOUT FALLING, BEGAN USE OF A CANE IN 2003, NUMBNESS IN EXTREMITIES, TINGLING OF EXTREMITIES, NEUROPATHY, AND ANEMIA WAS DIAGNOSED IN 1996. THE CONSUMER RECEIVED 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 Disability