BEUDAMED
    FDA Adverse Event Other Summary report: N

    EFFERGRIP DENTURE ADHESIVE CREAM

    MDR report key: 601731 · Received May 9, 2005

    Report

    Report Number
    2246407-2005-00004
    Event Type
    Other
    Date Received
    May 9, 2005
    Date of Event
    April 26, 2005
    Report Date
    May 3, 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

    CONSUMER, WITH A HISTORY OF SIMILAR REACTIONS TO DENTURE PRODUCTS, INITIATED USE OF EFFERGRIP DENTURE ADHESIVE. ONE APPLICATION, IN 2005 AS ADHESIVE FOR CONSUMER'S DENTURES. A SHORT TIME LATER THAT DAY, CONSUMER HAD AN ALLERGIC REACTION, WITH ITCHING, SWELLING AND REDNESS OF THE FACE. CONSUMER ALSO REPORTED "AFIB", OR IRREGULAR HEARTBEAT. CONSUMER TREATED THE EVENTS WITH A COLD COMPRESS. THE EVENTS RESOLVED THREE HOURS LATER.

    Description of Event or Problem · 1

    FOLLOW-UP #1: INVESTIGATION SUMMARY REC'D ON 06/01/2005 FROM PFIZER'S QUALITY OPERATIONS/PRODUCT COMPLAINTS GROUP: "THE INVESTIGATION WAS APPROVED AT THE SITE ON 05/31/05 AND APPROVED BY COQA. A REVIEW OF THE LOT DOCUMENTS DID NOT IDENTIFY ANY DISCREPANCIES. BULK AND FINISHED PRODUCT TESTING MET SPECIFICATIONS. RETAIN SAMPLE ANALYSIS REVEALS THE LOT MEETS SPECIFICATIONS. NO COMPLAINT SAMPLE WAS REC'D. NO FURTHER INVESTIGATION CAN BE THE PRODUCT WAS NOT RETURNED FOR FAILURE ANALYSIS/LABORATORY TESTING. IT CANNOT BE RULED OUT THAT THE PRODUCT MAY HAVE POSSIBILY CAUSED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFERGRIP DENTURE ADHESIVE CREAM DENTURE PRODUCT KOO PFIZER INC. UNK 197X4C

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other