BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOLLAR GENERAL EFFERVESCENT DENTURE CLEANSER

    MDR report key: 1264071 · Received December 11, 2008

    Report

    Report Number
    1219540-2008-00004
    Event Type
    Injury
    Date Received
    December 11, 2008
    Date of Event
    April 16, 2008
    Report Date
    December 11, 2008
    Manufacturer
    TOWER LABORATORIES, LTD.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER THE FDA'S REQUIREMENT, TOWER LABORATORIES, LTD AND STORE HAVE REVISED THE LABEL TO INCLUDE THE STATEMENT THAT THE PRODUCT CONTAINS PERSULFATES WHICH ARE A KNOWN ALLERGEN. ATTACHED IS A COPY OF THE REVISED LABEL.

    Description of Event or Problem · 1

    PATIENT HAD BEGUN USING EFFERVESCENT DENTURE CLEANSER AT THE BEGINNING OF 2008 USING ONE DENTURE TABLET DAILY TO CLEAN HIS DENTURES. HE SUDDENLY DEVELOPED AN ITCHY RASH IN VARIOUS PLACES ON HIS BODY. THE PATIENT WENT TO HIS PRIMARY CARE PHYSICIAN 2008, AND WAS PRESCRIBED TRIAMCINOLONE FOR THE ITCHY RASH. THE MEDICATION PROVIDED VERY LITTLE RELIEF AND WAS REFERRED TO A DERMATOLOGIST WHO PRESCRIBED FLUOCINONIDE. FOURTEEN DAYS LATER, THE PATIENT WOKE UP IN THE EARLY MORNING HAVING AN ANAPHYLACTIC EPISODE WITH HIS TONGUE DRASTICALLY SWOLLEN. THE PATIENT DID NOT GO TO THE EMERGENCY ROOM BUT WAS SEEN THAT DAY BY THREE DIFFERENT DOCTORS, IN WHICH THE LAST DOCTOR PRESCRIBED XYZAL, NASACORT AQ, AND AN EPIPEN. PATIENT WAS ALSO ORDERED A BATTERY OF ALLERGY TESTS. WHEN THE TIME CAME TO PERFORM THE ALLERGY TESTING, THE ALLERGIST INSTRUCTED THE PATIENT TO STOP ALL MEDICATIONS FOR SEVERAL DAYS PRIOR TO THE TESTING. AS A RESULT OF NOT TAKING THE MEDICATION, THE PATIENT ENDED UP AT THE EMERGENCY ROOM TWO MONTHS LATER, WITH DIFFICULTY BREATHING AND SWOLLEN THROAT. PATIENT STOPPED USING THE EFFERVESCENT DENTURE CLEANSER TWO MONTHS LATER, BUT CONTINUED TO EXPERIENCE SYMPTOMS WHEN HE WORE HIS DENTURES AND DID NOT TAKE THE PRESCRIBED MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOLLAR GENERAL EFFERVESCENT DENTURE CLEANSER EFFERVESCENT ANTIBACTERIAL DENTURE CLEANSER EFT TOWER LABORATORIES, LTD. 71101-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R