BEUDAMED
    FDA Adverse Event Other Summary report: N

    EQUATE ANTIBACTERIAL DENTURE CLEANSER TABLETS

    MDR report key: 2231579 · Received August 24, 2011

    Report

    Report Number
    1219540-2011-00011
    Event Type
    Other
    Date Received
    August 24, 2011
    Date of Event
    July 7, 2011
    Report Date
    August 24, 2011
    Manufacturer
    TOWER LABORATORIES, LTD.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER CALLED ON BEHALF OF A PATIENT WHO WAS USING THE PRODUCT TO CLEAN HIS PARTIAL DENTURES. HE DEVELOPED A RED, BLISTER RASH INSIDE HIS MOUTH. HIS LIPS WERE CHAPPED AND SWOLLEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUATE ANTIBACTERIAL DENTURE CLEANSER TABLETS EFFERVESCENT DENTURE CLNR EFT TOWER LABORATORIES, LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other