BEUDAMED
    FDA Adverse Event Death Summary report: N

    EFFERDENT ANTIBACTERIAL DENTURE CLEANSER

    MDR report key: 317866 · Received February 26, 2001

    Report

    Report Number
    2623619-2001-00003
    Event Type
    Death
    Date Received
    February 26, 2001
    Date of Event
    December 25, 2000
    Report Date
    February 23, 2001
    Manufacturer
    WARNER LAMBERT CO.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT'S FAMILY MEMBER REPORTED THAT PT GARGLED WITH THE EFFERDENT ANTIBACTERIAL DENTURE CLEANSER SOLUTION (POTASSIOUM MONOPERSULFATE, NA PERBORATE MONOHYDRATE) APPROXIMATELY AT MIDNIGHT ON 24-DEC-00. THEN, APPROXIMATELY AT 4:00 AM ON 25-DEC-00, PT AWOKE SCREAMING AND WHEEZING. PT BECAME UNSONSCIOUS AND THEIR TONGUE WAS NOTED AS SWOLLEN AND BLUE. THE FAMILY MEMBER REPORTED THAT PT HAD USED EFFERDENT ANTIBACTERIAL DENTURE CLEANSER FOR YEARS, ALWAYS GARGLING WITH THE PRODUCT, WITHOUT INCIDENT. PT HAD A SIMILAR REACTION IN THE PAST IN WHICH PT HAD DIFFICULTY BREATHING AFTER USING ANOTHER DENTURE CLEANSER, COLGATE-CORREGA. PT ALSO HAD AN ALLERGIC REACTION TO A DYE FOR AN INTRA-VENOUS PYELOGRAM. THIS REACTION INCLUDED VERTIGO, DELIRIOUM, MOTION SICKNESS AND WEAKNESS. THE PT'S FAMILY MEMBER ALSO REPORTED THAT PT'S DEATH CERTIFICATE STATED THEIR CAUSE OF DEATH AS A CARIO-PULMONARY ARREST. NO AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    A PT WITH A HISTORY OF DIABETES, CAROTID ARTERY DISEASE WITH BILATERAL OBSTRUCTION, CARDIAC DISEASE AND HYPERCHOLESTEROLEMIA, USED EFFERDENT ANTIBACTERIAL DENTURE CLEANSER (POTASSIUM MONOPERSULFATE, NA PERBORATE MONOHYDRATE) FROM 1997 THROUGH 2000 FOR DENTURE CARE. THE PT'S FAMILY MEMBER REPORTED THAT IN 2000 THE PT SOAKED DENTURES IN EFFERDENT SOLUTION AND THEN GARGLED WITH THE REMAINING EFFERDENT SOLUTION. THE PT'S TONGUE BECAME SWOLLEN AND BLUE. EMERGENCY PARAMEDICS ARRIVED. CARDIOPULMONARY RESUSCITATION WAS PERFORMED IMMEDIATELY. THE PT WAS TREATED WITH ISORDIL (ISOSORBIDE DINITRATE) BUT WAS PRONOUNCED DEAD AT THE SCENE. THE PT'S PHYSICIAN REPORTED THAT THE PT'S LAST VISIT WAS IN 2000. THE PT HAD A MEDICAL HISTORY OF DIABETES, AORTIC VALVE STENOSIS, ANGINA PECTORIS, CAROTID ARTERY DISEASE WITH BILATERAL OBSTRUCTION, HYPERCHOLESTEROLEMIA, OSTEOARTHRITIS AND WORK-RELATED PULMONARY ASBESTOSIS. THE PT'S MEDICATIONS INCLUDED DIABETA 5MG DAILY AND DAILY ASPIRIN. THE PT'S CARDIAC CONDITION AND HYPERCHOLESTEROLEMIA WERE CONTROLLED WITH DIET ONLY. AS THE PT'S LAST DOCTOR'S VISIT THE PT'S ANGINA PECTORIS WAS STABLE. THE PT'S BLOOD TESTS IN JUL-2000 INCLUDED A BLOOD GLUCOSE LEVEL OF 130 MG/DL, CHOLESTEROL 197 AND TRIGLYCERIDES 72. THE CAUSE OF DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    THE CAUSE OF DEATH WAS A CARDIOPULMONARY ARREST DUE TO ESOPHAGEAL SPASMS. THE PT HAD BEEN DIAGNOSED WITH ESOPHAGEAL SPASMS. THE PT HAD BEEN DIAGNOSED WITH ESOPHAGEAL SPASMS IN 1996. NO AUTOPSY WAS PERFORMED. QUALITY CONTROL REPORTED THAT THE COMPLAINT SAMPLE WAS NOT RETURNED FOR FAILURE ANALYSIS/LAB TESTING. HOWEVER, THE RESERVE SAMPLE WAS EVALUATED WITH THE FOLLOWING RESULTS: A REVIEW OF THE MFG AND PACKAGING RECORDS REVEALED NOTHING THAT MIGHT BE RELATED TO THE INCIDENT. ALL IN-PROCESS TEST RESULTS WERE SATISFACTORY. THE INITIAL RELEASE TESTING RESULTS MET PRODUCT SPECS. THE RESERVE SAMPLE WAS VISUALLY EXAMINED AND FOUND TO BE SATISFACTORY. THE RESERVE SAMPLE WAS TESTED AND MET SPECS FOR DISINTEGRATION TIME, PH, FADE TEST AND AVAILABLE OXYGEN. ALTHOUGH THE CHRONIC INCORRECT USE OF EFFERDENT MAY HAVE POSSIBLY EXACERBATED THE PT'S UNDERLYING CONDITION OF ESOPHAGEAL SPASMS, THE PT'S CARDIOPULMONARY ARREST AND DEATH IS MORE LIKELY DUE TO THE PT'S UNDERLYING CARDIAC MEDICAL HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7663 EFFERDENT ANTIBACTERIAL DENTURE CLEANSER DENTURE PRODUCT EFT WARNER LAMBERT CO. UNK A01370V

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death