BEUDAMED
    FDA Adverse Event Other Summary report: N

    EFFERGRIP DENTURE ADHESIVE CREAM

    MDR report key: 575183 · Received January 20, 2005

    Report

    Report Number
    2246407-2005-00002
    Event Type
    Other
    Date Received
    January 20, 2005
    Date of Event
    July 10, 2002
    Report Date
    January 18, 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

    PT INITIATED USE OF EFFERGRIP DENTURE ADHESIVE CREAM(CARBOXYMETHYLCELLULOSE SODIUM, MALEIC ANHYDRIDE, METHYL VINYL ETHER), 3 STRIPS DAILY, "YEAR AGO" TO SECURE THEIR DENTURES (DATES OF USE UNSPECIFIED). FAMILY MEMBER ALSO REPORTED THAT THEY HAVE BEEN TAKING COUMADIN (WARFARIN SODIUM) 2.5 MG DAILY FOR 5 YEARS STARTING IN 2002 AS A "BLOOD THINNER." THEY REPORTED THAT PT'S DENTIST "TOOK THEM OFF COUMADIN FOR A DENTAL PROCEDURE, THEY THEN HAD A STROKE (2002) (TREATMENT WAS NOT SPECIFIED) SINCE THE STROKE, THEY CANNOT TALK. THE CONSUMER ALSO REPORTED THAT PT SWALLOWS THE PRODUCT (DATES UNSPECIFIED). USE OF BOTH PRODUCTS CONTINUES AND THE OUTCOME OF THE EVENTS IS NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFERGRIP DENTURE ADHESIVE CREAM DENTURE PRODUCT KOO PFIZER INC. UNK 22384C

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other