BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECISLIDES

    MDR report key: 8353501 · Received February 20, 2019

    Report

    Report Number
    8353501
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    November 20, 2018
    Report Date
    November 29, 2018
    Manufacturer
    FISHER SCIENTIFIC CO.
    Product Code
    KEW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LAB RECEIVED 3 BOXES OF FISHERBRAND DECISLIDES TO READ URINE MICROSCOPICS. ALL THE SLIDES WERE BOWED MAKING THEM IMPOSSIBLE TO FOCUS AND READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148636 DECISLIDES SLIDES, MICROSCOPE KEW FISHER SCIENTIFIC CO. BP2152181

    Patients

    Seq Age Sex Outcome Treatment
    1