BEUDAMED
    FDA Adverse Event Other Summary report: N

    EFFERGRIP DENTURE ADHESIVE CREAM

    MDR report key: 626991 · Received August 11, 2005

    Report

    Report Number
    2246407-2005-00010
    Event Type
    Other
    Date Received
    August 11, 2005
    Date of Event
    July 31, 2005
    Report Date
    August 8, 2005
    Manufacturer
    PFIZER INC.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CONSUMER USED THREE 1/2 INCH LONG STRIPS OF EFFERGRIP DENTURE ADHESIVE CREAM (CARBOXYMETHYLCELLULOSE SODIUM, MALEIC ANHYDRIDE, METHYL VINYL ETHER) THREE TIMES BEGINNING IN JUL2005 TO ADHERE THEIR BOTTOM DENTURES. BEGINNING NEXT DAY, THEIR ENTIRE LOWER GUM, TISSUE BETWEEN THEIR GUMS AND CHEEK, AND THE RIGHT SIDE OF THEIR THROAT BECAME SWOLLEN. PT CONSULTED WITH THEIR PHYSICIAN AND WAS INFORMED THAT PT HAD AN ALLARGIC REACTION TO EFFERGRIP. THE CONSUMER APPLIED ICE TO THE AREAS AND RECEIVED A CORTISONE INJECTION IN AUG2005. PRODUCT USE WAS DISCONTINUED IN AUG2005. THE EVENTS RESOLVED TWO DAYS LATER.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION RECEIVED BY PFIZER IN NOV. 2005 FROM THE CONSUMER'S PHYSICIAN: THE PHYSICIAN REPORTED THAT THE PT WAS SEEN IN HIS OFFICE IN AUG 2005. HE DID NOT KNOW IF SHE HAD A REACTION TO EFFERGRIP OR NOT.

    Description of Event or Problem · 1

    A FEMALE CONSUMER USED THREE 1/2 INCH LONG STRIPS OF EFFERGRIP DENTURE ADHESIVE CREAM (CARBOXYMETHYLCELLULOSE SODIUM, MALEIC ANHYDRIDE, METHYL VINYL ETHER) THREE TIMES BEGINNING IN 2005 TO ADHERE HER BOTTOM DENTURES. BEGINNING IN 2005, HER ENTIRE LOWER GUM, TISSUE BETWEEN HER GUMS AND CHEEK, AND THE RIGHT SIDE OF HER PHYSICIAN AND WAS INFORMED THAT SHE HAD AN ALLERGIC REACTION TO EFFERGRIP. THE CONSUMER APPLIED ICE TO THE AREAS AND RECEIVED A CORTISONE INJECTION IN 2005. THE EVENTS RESOLVED TWO DAYS LATER. FOLLOW -UP 1. FOLLOW-UP INFO RECEIVED BY PFIZER IN 2005 FROM PFIZER QUALITY OPERATIONS/PRODUCT COMPLAINTS GROUP: INVESTIGATION APPROVED AT SITE LEVEL IN 2005 AND BY COQA IN 2005. A FULL DOCUMENTATION REVIEW, INCLUDING BATCH RECORD, RAW MATERIALS,AND PACKAGING RECORD DID NOT INDICATE ANY DISCREPANCIES. RETAINS FOR HIS LOT REMAIN WITHIN SPECIFICATIO FOR TOLUENE EXTRACTABLES, OIL SEPARATION, AND DESCRIPTION. THE CAUSE IS UNK. NO CORRECTIVE ACTIONS WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFERGRIP DENTURE ADHESIVE CREAM DENTURE PRODUCT EFT PFIZER INC. UNK 11765C

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other