BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E.P.T

    MDR report key: 566028 · Received January 2, 2005

    Report

    Report Number
    MW1034191
    Event Type
    Malfunction
    Date Received
    January 2, 2005
    Date of Event
    January 2, 2005
    Report Date
    January 2, 2005
    Manufacturer
    WARNER LAMBERT
    Product Code
    LCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER RECEIVING A NEGATIVE TEST RESULT FROM A HOME PREGNANCY TEST -HTP-, PT RESEARCHED THE ACCURACY OF THESE FDA-APPROVED PRODUCTS ONLINE AND WAS DISTURBED TO FIND TAHT THE "99% ACCURACY" CLAIM OF ALL THESE PRODUCTS IS FALSE, ACCORDING TO A STUDY PUBLISHED IN THE AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY IN JAN. 2004. AS THE STUDY STATES, IT IS DANGEROUS FOR A PREGNANT WOMAN WHO RECEIVES A NEGATIVE TEST RESULT--AND BELIEVES IT DUE TO THE BLATANT CLAIM OF 99% ACCURACY--TO NOT TAKE APPROPRIATE STEPS TOWARDS A HEALTHY PREGNANCY. REPORTER FEELS IT IS UNSCRUPULOUS TO MAKE SUCH A FRAUDULENT CLAIM WHEN THE ISSUE IS A WOMEN'S PREGNANCY. RPTR FEELS THE FDA SHOULD DEMAND THAT THE MFRS CLARIFY THE ACCURACY OF THEIR PRODUCTS.

    Description of Event or Problem · 1

    WARNER LAMBBERT CO, LLC ("WARNER LAMBERT"), WHICH DOES BUSINESS AS PFIZER CONSUMER HEALTHCARE, RECEIVED THE ABOVE MAUDE EVENT REPORT RELATED TO E.P.T. HOME PREGNANCY TEST KIT FROM FDA ON 4/14/2005. AS REQUESTED IN FDA'S COVER LETTER, WE ARE WRITING TO INFORM YOU THAT WARNER LAMBERT DOES NOT MFR E.P.T. HOME PREGNANCY TEST KITS. THE TEST KITS ARE MFG BY UNIPATH LTD IN BEDFORD, UK, FOR DISTRIBUTION BY WARNER LAMBERT UNDER E.P.T. BRAND NAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E.P.T PREGNANCY TEST LCX WARNER LAMBERT * PD0011H

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other