BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL CHOLESTEROL TEST KIT

    MDR report key: 378364 · Received February 8, 2002

    Report

    Report Number
    MW1024125
    Event Type
    Malfunction
    Date Received
    February 8, 2002
    Report Date
    February 8, 2002
    Manufacturer
    BIOSAFE DIAGNOSTIC PRODUCTS, INC.
    Product Code
    NFX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE EBIOSAFE CHOLESTEROL KIT IS LABELED AS "OUCHLESS" AND "PAINLESS" THIS IS A MISREPRESENTATION. THE LANCET THEY USE IS NOT OUCHLESS OR PAINLESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL CHOLESTEROL TEST KIT CHOLESTEROL TEST NFX BIOSAFE DIAGNOSTIC PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other