BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 183289 · Received August 6, 1998

    Report

    Report Number
    MW4002320
    Event Type
    Malfunction
    Date Received
    August 6, 1998
    Report Date
    May 27, 1998
    Manufacturer
    MEDI-SOURCE, INC.
    Product Code
    KEW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    SLIDES ARE DIRTY, HAVE A GREASY FILM AND THE EDGES ARE CHIPPED AND ROUGH. THE SLIDES ARE UNACCEPTABLE FOR MAKING BLOOD DIFFERENTIAL SMEARS. POOR WORKMANSHIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI MICROSCOPE SLIDES, FROSTED KEW MEDI-SOURCE, INC. 71515 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA