BEUDAMED
    FDA Adverse Event Other Summary report: N

    EFFERDENT UNSPECIFIED

    MDR report key: 408086 · Received July 26, 2002

    Report

    Report Number
    2623619-2002-00001
    Event Type
    Other
    Date Received
    July 26, 2002
    Date of Event
    June 4, 2002
    Report Date
    July 11, 2002
    Manufacturer
    PFIZER INC.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A NURSE REPORTED THAT PT, WITH A HISTORY OF DEMENTIA, MAY HAVE MISTAKENLY INGESTED EFFERDENT TABLETS-FORMULATION UNSPECIFIED (POTASSIUM MONOPERSULFATE, SODIUM PERBORATE MONOHYDRATE) FOR SEVERAL WEEKS IN JUN-02, THINKING THEY WERE TUMS. ON THE DAY OF THE EVENT, THE PT COMPLAINED OF STOMACH PAIN AND A "GURGLING" SOUND COULD BE HEARD FROM PT'S ABDOMEN. PT WAS TAKEN TO THE EMERGENCY ROOM A TOTAL OF 4 TIMES, THE LAST BEING ON TWO DAYS PRIOR TO THE EVENT. UNSPECIFIED LAB TESTS WERE PERFORMED DURING PT'S E.R. VISITS WITH NORMAL RESULTS. DURING TWO EMERGENCY ROOM VISITS PT WAS TREATED WITH INTRAVENOUS REGLAN (METACLOPRAMIDE). AS OF JUN-02, PT IS TAKING CARAFATE (SUCRALFATE) FOR STOMACH PAIN AND THE EVENT HAS NOT YET RESOLVED. IT IS UNKNOWN IF INGESTION OF EFFERDENT WAS STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFERDENT UNSPECIFIED DENTURE PRODUCT EFT PFIZER INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other