BEUDAMED
    FDA Adverse Event Other Summary report: N

    EFFERDENT

    MDR report key: 769737 · Received October 10, 2006

    Report

    Report Number
    2246407-2006-00009
    Event Type
    Other
    Date Received
    October 10, 2006
    Date of Event
    October 1, 2006
    Manufacturer
    PFIZER INC
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN 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

    A DAUGHTER REPORTED, HER MOTHER USED ONE EFFERDENT (FORMULATION UNSPECIFIED) (SODIUM PERBORATE MONOHYDRATE, POTASSIUM MONOPERSULFATE) DAILY, BEGINNING ON AN UNKNOWN DATE IN 2003, FOR DENTURE CLEANING. CONSUMER ALSO USED AN UNSPECIFIED MOUTHWASH (DOSE, FREQUENCY, DATE OF INDICATION UNKNOWN). IN 2006, SHE HAD AN ALLERGIC REACTION AND HER TONGUE SWELLED AND "PURTUED" OUT OF HER MOUTH. THE CONSUMER WAS TAKEN TO THE EMERGENCY ROOM WHERE SHE WAS TREATED WITH STEROIDS (UNSPECIFIED) AND BENADRYL (DIPHENHYDRAMINE). THAT SAME DAY, EFFERDENT USE WAS DISCONTINUED. IT WAS UNKNOWN IF THE EVENT RESOLVED AND IF THE MOUTHWASH USE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFERDENT DENTURE PRODUCT EFT PFIZER INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other