BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1661742 · Received April 15, 2010

    Report

    Report Number
    1530449-2010-00063
    Event Type
    Other
    Date Received
    April 15, 2010
    Report Date
    March 23, 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 THE REPORTER; THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    NEUROPATHY [NEUROPATHY PERIPHERAL], UNABLE TO WALK UNASSISTED [GAIT DISTURBANCE]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, A FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, ORIGINAL CREAM UNK, AS HER DENTURE ADHESIVE OF CHOICE, AND REPORTED THE FOLLOWING: NEUROPATHY; UNABLE TO WALK UNASSISTED. SHE HAS RECEIVED MEDICAL CARE AND UNSPECIFIED TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER SINCE SHE WAS (B)(6). 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 MFG CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Disability