BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE

    MDR report key: 1661744 · Received April 15, 2010

    Report

    Report Number
    1530449-2010-00064
    Event Type
    Other
    Date Received
    April 15, 2010
    Report Date
    April 5, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NEUROPATHY [NEUROPATHY PERIPHERAL]. CANNOT WALK ON OWN [GAIT DISTURBANCE]. CASE DESCRIPTION: A REGULATORY AUTHORITY REP REPORTED THAT THEY WERE NOTIFIED THAT A CONSUMER, GENDER AND AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM 1 APPLICATION, 1 /DAY BEGINNING 1997 THROUGH 2010 AND REPORTED THE FOLLOWING: NEUROPATHY AND CANNOT WALK ON OWN ANYMORE, IS IN A WHEELCHAIR. 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 UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE NONE KOO PROCTER & GAMBLE MFG CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability