BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHOLESTRAK

    MDR report key: 562787 · Received December 7, 2004

    Report

    Report Number
    MW1033964
    Event Type
    Other
    Date Received
    December 7, 2004
    Date of Event
    January 1, 2004
    Report Date
    November 18, 2004
    Manufacturer
    ACCUTECH, LLC
    Product Code
    NFX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS IS NOT THE FIRST TIME STORE HAS EXPIRED PRODUCTS FOR SALE. IF ONE IS NOT FEELING WELL, ONE IS NOT ALERT ENOUGH TO NOTICE THESE THINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLESTRAK CHOLESTEROL MEASURING DEVICE NFX ACCUTECH, LLC * UPC 7-8376280202

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other