BEUDAMED
    FDA Adverse Event Death Summary report: N

    EFFERDENT PLUS DENTURE CLEANSER

    MDR report key: 334630 · Received May 22, 2001

    Report

    Report Number
    2623619-2001-00004
    Event Type
    Death
    Date Received
    May 22, 2001
    Date of Event
    May 10, 2001
    Report Date
    May 14, 2001
    Manufacturer
    WARNER-LAMBERT CO.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A NURSE PRACTITIONER REPORTED THAT PATIENT, WITH HISTORY OF ALZHEIMER'S DEMENTIA, CONFUSION AND PARANOIA, ACCIDENTALLY ATE ONE TABLET OF EFFERDENT PLUS DENTURE CLEANSER (POTASSIUM MONOPERSULFATE; NA PERBORATE MONOHYDRATE) IN MAY 2001. AFTER THE INGESTION PATIENT VOMITED A GREEN SUBSTANCE AND WAS DELERIOUS. THAT SAME DAY, THE PATIENT WAS TAKEN TO AN EMERGENCY ROOM. BLOOD TESTS WERE PERFORMED. BLOOD UREA NITROGEN, SERUS CREATININE, GLUCOSE AND ALKALINE PHOSPHATASE LEVELS WERE ELEVATED. BLOOD PROTEINS WERE SLIGHTLY ELEVATED. HYPOVOLEMIA, CHRONIC RENAL FAILURE AND SHINGLES WERE DIAGNOSED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND PLACED UNDER OBSERVATION. INTRAVENOUS FLUID HYDRATION WAS ADMINISTERED AND PATIENT WAS DISCHARGED ON THE FOLLOWING DAY. INTRAVENOUS FLUIDS WERE CONTINUED IN THE NURSING HOME. THE PATIENT SUBSEQUENTLY DIED THE NEXT DAY AT 6:15 AM. THE CAUSE OF DEATH WAS PANCREATITIS. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23893 EFFERDENT PLUS DENTURE CLEANSER DENTURE PRODUCT EFT WARNER-LAMBERT CO. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| H