BEUDAMED
    FDA Adverse Event Other Summary report: N

    EFFERDENT ANTIBACTERIAL DENTURE CLEANSER

    MDR report key: 5409893 · Received March 1, 2005

    Report

    Report Number
    2246407-2005-00014
    Event Type
    Other
    Date Received
    March 1, 2005
    Date of Event
    January 1, 2003
    Report Date
    February 25, 2005
    Manufacturer
    PFIZER INC.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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

    A CURRENTLY (B)(6) ELDERLY MALE CONSUMER BEGAN USING ONE TABLET OF EFFERDENT ANTI-BACTERIAL DENTURE CLEANSER (SODIUM PERBORATE MONOHYDRATE, POTASSIUM MONOPERSULFATE) 1 TO 2 TIMES PER DAY BEGINNING IN 1997 (EXACT DATE UNSPECIFIED) TO CLEAN HIS DENTURES. BEGINNING IN (B)(6) OF (EXACT DATE UNKNOWN), HE HAD THROAT CANCER. THE CANCER WAS TREATED WITH AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2004. AS OF (B)(6) 2005, PRODUCT USE CONTINUES. THE EVENT RESOLVED ON AN UNSPECIFIED DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFERDENT ANTIBACTERIAL DENTURE CLEANSER DENTRUE PRODUCT EFT PFIZER INC. UNK AE30X4V

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other