BEUDAMED
    FDA Adverse Event Other Summary report: N

    EFFERGRIP DENTURE ADHESIVE CREAM

    MDR report key: 562407 · Received December 22, 2004

    Report

    Report Number
    2246407-2004-00003
    Event Type
    Other
    Date Received
    December 22, 2004
    Date of Event
    January 1, 2004
    Report Date
    December 22, 2004
    Manufacturer
    PFIZER INC.
    Product Code
    KOT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT A PT WITH A HISTORY OF AN UNSPECIFIED SKIN PROBLEM BEGAN USING ONE APPLICATION OF EFFERGRIP DENTURE ADHESIVE CREAM (CARBOXYMETHYLCELLULOSE SODIUM; MALEIC ANHYDRIDE; METHYL VINYL ETHER) DAILY AS NEEDED IN 2004 TO HOLD THEIR DENTURES IN PLACE. AFTER PRODUCT USE THEY HAD RED, RAISED HIVES ALL OVER THEIR FACE. IN 12/2004 THEY HAD EYE SURGERY TO LIFT THE BOTTOM LEFT EYELID. AFTER THE SURGERY THE CONSUMER WAS PRESCRIBED ERYTHROMYCIN OINTMENT (0.5% DAILY). THE HIVES WERE TREATED WITH BENADRYL 25 MG (UNSPECIFIED GENERIC KIRKLAND BRAND). AS OF 10 DAYS LATER THE CONSUMER IS CONTINUING USE OF EFFERGRIP. THE OUTCOME WAS REPORTED AS NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFERGRIP DENTURE ADHESIVE CREAM DENTURE PRODUCT KOT PFIZER INC. UNK 10110C

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other