BEUDAMED
    FDA Adverse Event Other Summary report: N

    DAKOLINK TISSUE CASSETTES

    MDR report key: 1403331 · Received June 12, 2009

    Report

    Report Number
    2022180-2009-00002
    Event Type
    Other
    Date Received
    June 12, 2009
    Date of Event
    May 28, 2009
    Report Date
    June 5, 2009
    Manufacturer
    DAKO NORTH AMERICA, INC.
    Product Code
    IDZ
    PMA / PMN Number
    CLASS I
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LIP TISSUE SAMPLE WAS PLACED IN TISSUE CASSETTE FOR PROCESSING. THE PROBLEM OCCURRED DURING THE FORMALIN FIXATION STEP, WHICH CONSISTS OF THE CASSETTES BEING PLACED IN THE RETORT CHAMBER OF THE SAKURA VIP5 TISSUE PROCESSOR SET AT 45 DEGREES C WITH SLIGHT AGITATION UNDER VACUUM AND PRESSURE. CASSETTES ARE SET IN RACKS THAT FIT THE CHAMBER WITH NINE CASSETTES PER SPACE, ALLOWING ROOM BETWEEN CASSETTES FOR THE REAGENT TO FLOW FREELY. DURING THIS STEP, THE CASSETTE OPENED AND THE SAMPLE FELL OUT. THE SAMPLE COULD NO LONGER BE IDENTIFIED AND NO ADD'L TISSUE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAKOLINK TISSUE CASSETTES TISSUE CASSETTES IDZ DAKO NORTH AMERICA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other