BEUDAMED
    FDA Adverse Event Other Summary report: N

    EQUATE DOUBLE ACTION DENTURE CLEANSER TABLETS

    MDR report key: 2092948 · Received May 11, 2011

    Report

    Report Number
    1219540-2011-00008
    Event Type
    Other
    Date Received
    May 11, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 5, 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

    CONSUMER STATED THAT HE EXPERIENCED SWELLING OF THE ORAL CAVITY AFTER USING THE EQUATE DOUBLE ACTION DENTURE CLEANSER. HE LOOKED LIKE HE GOT HIT IN THE JAW. HE PUT THE DENTURE IN HIS MOUTH WITHOUT PROPERLY CLEANSING/RINSING THE DENTURES. CONSUMER STATED HE BEGAN USING THE PRODUCT ON (B)(6) 2011 AND STOPPED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUATE DOUBLE ACTION DENTURE CLEANSER TABLETS EFFERVESCENT DENTURE CLNR EFT TOWER LABORATORIES, LTD. 01006-7

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other