BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1651953 · Received April 5, 2010

    Report

    Report Number
    1530449-2010-00054
    Event Type
    Other
    Date Received
    April 5, 2010
    Report Date
    September 8, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OR PRODUCT WAS NOT PROVIDED, THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    CANNOT WALK [ABASIA], CANNOT STAND [DYSSTASIA], LOSS USE OF LEGS, LEGS COLLAPSE [LOSS OF CONTROL OF LEGS], NO BALANCE [BALANCE DISORDER]. CASE DESCRIPTION: A CONSUMER REPORTED THAT HER HUSBAND, AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, ORIGINAL CREAM 1 APPLIC, 8-9 TIMES A DAY FOR 10 YEARS AND REPORTED THE FOLLOWING: CANNOT STAND, CANNOT WALK, LOSS USE OF LEGS, LEGS COLLAPSE, NO BALANCE. THE CONSUMER'S HUSBAND USES A WHEELCHAIR. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION 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 NONE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability