BEUDAMED
    FDA Adverse Event Other Summary report: N

    EFFERGRIP DENTURE ADHESIVE CREAM

    MDR report key: 672752 · Received February 6, 2006

    Report

    Report Number
    2246407-2006-00001
    Event Type
    Other
    Date Received
    February 6, 2006
    Date of Event
    January 1, 2004
    Report Date
    January 12, 2006
    Manufacturer
    PFIZER INC.
    Product Code
    KOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PATIENT BEGAN USING EFFERGRIP DENTURE ADHESIVE CREAM (CARBOXYMETHYLCELLULOSE SODIUM, MALEIC ANHYDRIDE, METHYL VINYL ETHER) 4-5 TIMES DAILY TO HOLD HIS DENTURES APPROXIMATELY IN 2004. THE CONSUMER REPORTED THAT HE HAS BEEN USING THE PRODUCT 4-5 TIMES DAILY SINCE THE PRODUCT ONLY HOLDS HIS DENTURES FOR ABOUT 2 HOURS. AS OF DEC 2005 HE WAS CONTINUING TO USE THE PRODUCT. ADDITIONAL INFORMATION RECEIVED BY PFIZER IN JAN 2006 UPGRADES THIS CASE TO SERIOUS: THE PATIENT REPORTED HE HAS BEEN USING THE PRODUCT FOR ONE AND A HALF YEARS, 6 TIMES A DAY AND HAS BEEN HAVING SLEEP APNEA AND CENTRAL NERVOUS SYSTEM DISORDER DESCRIBED AS FACIOSCAPULOHUMERAL. HE NO LONGER USES THE PRODUCT AND THE OUTCOME OF THE EVENTS IS UNKNWON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFERGRIP DENTURE ADHESIVE CREAM DENTURE PRODUCT KOQ PFIZER INC. UNK 102840

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other