BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXODENT EXTRA HOLD

    MDR report key: 1842514 · Received September 20, 2010

    Report

    Report Number
    MW5017491
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    April 1, 1994
    Report Date
    September 8, 2010
    Manufacturer
    PROCTER & GAMBLE
    Product Code
    KOO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I STARTED USING FIXODENT FROM AROUND (B)(6) 1994 UNTIL (B)(6) 2010. I HAVE EXPERIENCED TINGLING WITH NUMBNESS AND ITCHINESS AS IF ALLERGIC TO SOMETHING. AS OF (B)(6)2010, I HAVE DONE BLOOD-WORK WITH LABS. AWAITING RESULTS FROM LABS. EXTREME CRAMPING IN EXTREMITIES. I STARTED USING FIXODENT (PROCTER AND GAMBLE) APPROX (B)(6) 1994 UNTIL (B)(6) 2010. EXPERIENCED TINGLING, NUMBNESS, WITH CRAMPS WITH SOME ITCHINESS TO MY FACE AND EXTREMITIES. DOSE OR AMOUNT: DENTURE CREAM; FIXODENT POWDER. FREQUENCY: TWICE DAILY; ONCE DAILY. ROUTE: ORAL; ORAL. DATES OF USE: (B)(6)1994 - (B)(6)2010. DIAGNOSIS OR REASON FOR USE: DENTURE ADHESIVE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT EXTRA HOLD NONE KOO PROCTER & GAMBLE UNK
    2 FIXODENT COMPLETE NONE KOO PROCTER & GAMBLE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| S NO KNOWN PRODUCT USE.