BEUDAMED
    FDA Adverse Event Other Summary report: N

    EFFERGRIP DENTURE ADHESIVE CREAM

    MDR report key: 568355 · Received January 19, 2005

    Report

    Report Number
    2246407-2005-00001
    Event Type
    Other
    Date Received
    January 19, 2005
    Date of Event
    December 1, 2004
    Report Date
    January 14, 2005
    Manufacturer
    PFIZER INC.
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER INITIATED USE OF EFFERGRIP DENTURE ADHESIVE (CARBOXYMETHYLCELLULOSE SODIUM, MALEIC ANHYDRIDE, METHYL VINYL ETHER), "ENOUGH TO HOLD THEIR DENTURES", DAILY IN JUL-2004. BEGINNING IN 2004, (EXACT DATE UNSPECIFIED), PT HAD A RASH ON THEIR LEGS AND BUTTOCKS, SWELLING OF THEIR FEET, AND THE FINGERS ON THEIR LEFT HAND TURNED BLUE. PT WAS ADMITTED TO THE HOSPITAL FOR 1 WEEK, WHERE UNSPECIFIED BLOOD TESTS WERE PERFORMED (ALL NORMAL) AND AN ARTERIOGRAM WAS NORMAL ("NO CLOGGED ARTERIES"). PT WAS DISCHARGED IN JAN-2005. PT RECEIVED TREATMENT WITH PREDISONE FOR 3 WEEKS TO TREAT THE EVENTS. THE CONSUMER REPORTED THAT THEIR SMOKING HISTORY WAS AFFECTING THEIR CAPILLARIES. PT CONTINUES TO USE THE PRODUCT. AS OF 4 DAYS LATER, THE RASH IS RESOLVING AND THE SWELLING AND DISCOLORATION "COMES AND GOES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFERGRIP DENTURE ADHESIVE CREAM DENTURE PRODUCT KOO PFIZER INC. UNK 113D2C

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| O