BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EFFERDENT ANTIBACTERIAL DENTURE CLEANSER

    MDR report key: 450607 · Received March 26, 2003

    Report

    Report Number
    2623619-2003-00001
    Event Type
    Injury
    Date Received
    March 26, 2003
    Date of Event
    March 11, 2003
    Report Date
    March 24, 2003
    Manufacturer
    PFIZER, INC.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A CONSUMER WHO IS ALLERGIC TO SULFA, USED ONE EFFERDENT ANTI BACTERIAL DENTURE CLEANSING TABLET (POTASSIUM MONOPERSULFATE, SODIUM PERBORATE MONOHYDRATE) ONCE FOR DENTURE CARE. AFTER USING THE PRODUCT, THEIR TONGUE SWELLED. THEY WERE TAKEN TO THE EMERGENCY ROOM WHERE THEY WERE TREATED WITH INTRAVENOUS STEROIDS AND BENADRYL. THEY WERE ADMITTED FOR 24 HOURS FOR OBSERVATION. 2 DAYS LATER, AFTER WASHING THEIR DENTURES THOROUGHLY, PT PLACED THEM BACK IN THEIR MOUTH AND HAD THE SAME REACTION. THEY WERE TAKEN TO THE HOSPITAL AND TREATED WITH INTRAVENOUS STEROIDS AND BENADRYL AGAIN. THEY WERE NOT ADMITTED, BUT DISCHARGED WITH ORAL STEROIDS. THEIR TONGUE SWELLING HAS DECREASED BUT HAS NOT COMPLETLY RESOLVED.

    Description of Event or Problem · 1

    RECEIVED INFO FORM INITIAL REPORTER CONTAINTING PTS DATE OF BIRTH

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFERDENT ANTIBACTERIAL DENTURE CLEANSER DENTURE PRODUCT EFT PFIZER, INC. UNK 01063V

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R