BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXODENT

    MDR report key: 1810705 · Received August 18, 2010

    Report

    Report Number
    MW5017122
    Event Type
    Injury
    Date Received
    August 18, 2010
    Manufacturer
    PROCTOR & GAMBLE
    Product Code
    KOO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE USED FIXODENT CONTINUOUSLY SINCE 1990. I NOTICED TINGLING AND NUMBNESS IN MY FEET WHICH WAS DIAGNOSED AS NEUROPATHY IN 2008. THIS DIAGNOSIS IS PERMANENT AND REQUIRES CONTINUED MEDICAL CARE AND TREATMENT. DOSE OR AMOUNT: DENTURE CREAM, FREQUENCY: 1 - 2 DAILY, ROUTE: ORAL. DATES OF USE: 1990 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: DENTURE ADHESIVE CREAM. EVENT ABATED AFTER USE: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT NONE KOO PROCTOR & GAMBLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S