BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EFFERDENT ANTIBACTERIAL DENTURE CLEANSER

    MDR report key: 539268 · Received August 13, 2004

    Report

    Report Number
    2623619-2004-00001
    Event Type
    Injury
    Date Received
    August 13, 2004
    Date of Event
    April 1, 2004
    Report Date
    August 9, 2004
    Manufacturer
    WARNER LAMBERT CO.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS IS A REPORT IN WHICH TWO DEVICES ARE IDENTIFIED AS SUSPECTS. THEREFORE, TWO MFR REPORT NUMBERS ARE BEING SUBMITTED IN ORDER TO COMPLY WITH FDA REGULATIONS MANDATING SEPARATE MFR REPORT NUMBERS FOR EACH DIFFERENT SUSPECT DEVICE. SEE MFR REPORT NUMBER 224276-2004-00001 FOR FRESH 'N BRITE (SILICON, SODIUM LAURYL SULFATE) AS SUSPECT DEVICE NUMBER ONE. A CONSUMER, WITH A HISTORY OF STROKE AND AN ALLERGY TO BLUE DYE, BEGAN USING EFFERDENT ANTI-BACTERIAL DENTURE CLEANSER (SODIUM PERBORATE MONOHYDRATE, POTASSIUM MONOPERSULFATE) TWICE DAILY (THERAPY DATE UNSPECIFIED) ALONG WITH A SMALL AMOUNT OF FRESH 'N BRITE DENTURE TOOTHPASTE (SILICON, SODIUM LAURYL SULFATE) SINCE 2003 TO KEEP THEIR DENTURES AND THE METAL WORK CLEAN IN 2004, WHILE GETTING UP FROM GOING TO THE BATHROOM, THE CONSUMER FELT WEAK AND FELL TO THEIR KNEES. THEY WERE UNABLE TO GET UP AND WAS TAKEN TO THE HOSPITAL IN FEAR OF A POSSIBLE STROKE RECURRENCE. WHILE IN THE HOSP, THEY HAD MYELOGRAM, BLOOD WORK, A BONE SCAN, AND AN ECG (ELECTROCARDIOGRAM) PERFORMED (RESULTS UNKNOWN). THEY REPORTED THAT THEY "BECAME AWARE THAT THEY HAD BEEN ACCUMULATING BLUE DYE IN THEIR BODY." THEY ALSO REPORTED THAT THEY HAD PASSED OUT ABOUT FOUR MONTHS AGO AND SINCE THEN, HAS GONE THROUGH 4 MONTHS OF TESTING INCLUDING AN MRI (MAGNETIC RESONANCE IMAGING), BONE SCAN, EEG (ELECTROENCEPHALOGRAM), COLONOSCOPY AND CAT SCAN TO DETERMINE WHY THEY HAD PASSED OUT. THEY INDICATED THAT THE RADIOCONTRAST DYES USED IN THESE TESTS MAY HAVE ACCUMULATED IN THEIR BODY. THEY SAID THAT DURING THEIR HOSPITALIZATION, PRODUCTS CONTAINING BLUE DYE INCLUDING THE PERCOCET (OXYCODONE/PARACETAMOL) GIVEN FOR PAIN IN THE HOSP, WERE ELIMINATED. THEREAFTER, THEY FELT BETTER AND THEIR WEAKNESS IMPROVED. THEY WERE DISCHARGED 3 DAYS LATER. THE USE OF EFFERDENT AND FRESH 'N BRITE WERE DISCONTINUED 3 DAYS AGO. IT IS UNKNOWN IF CONTRAST DYE CONTINUE TO BE USED FOR TESTS. AS OF THE FOLLOWING MONTH, THEIR WEAKNESS HAS IMPROVED AND THEY RECOVERED FROM THE FALL. THE CUSTOMER BELIEVES THEY ARE ALLERGIC TO DYE TNNC#1 (BLUE LAKE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFERDENT ANTIBACTERIAL DENTURE CLEANSER DENTURE PRODUCT EFT WARNER LAMBERT CO. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization