BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EFFERGRIP DENTURE ADHESIVE CREAM

    MDR report key: 1251991 · Received December 4, 2008

    Report

    Report Number
    2246407-2008-00012
    Event Type
    Injury
    Date Received
    December 4, 2008
    Report Date
    November 25, 2008
    Manufacturer
    JOHNSON AND JOHNSON GROUP OF CONSUMER COMPANIES
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR FAILURE ANALYSIS/LABORATORY TESTING. IT CANNOT BE RULED OUT THAT THE PRODUCT MAY HAVE POSSIBLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    THIS WAS A SPONTANEOUS REPORT RECEIVED FROM A DENTIST REPORTING ON A FEMALE PATIENT (AGE UNSPECIFIED). THE DENTIST REPORTED THAT A FEMALE PATIENT USED EFFERGRIP DENTURE ADHESIVE CREAM (CARBOXYMETHYLCELLULOSE SODIUM; MALEIC ANHYDRIDE; METHYL VINYL ETHER) (AMOUNT, FREQUENCY, DATES OF USE, AND INDICATION UNSPECIFIED). AFTER PRODUCT USE (DATE UNSPECIFIED), THE PATIENT HAD AN ALLERGIC REACTION AS HER MOUTH WAS RED AND BURNING. IN ADDITION, WHEN THE PATIENT SLEPT HER LUNGS STARTED TO "CLOSE UP". AS OF 2008, IT WAS UNK IF PRODUCT USE CONTINUED AND THE OUTCOME OF THE EVENTS WAS UNKNOWN. THE CASE IS SERIOUS (LIFE THREATENING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFERGRIP DENTURE ADHESIVE CREAM DENTURE PRODUCT KOL JOHNSON AND JOHNSON GROUP OF CONSUMER COMPANIES

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening