BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDE WHITE APEX SUPERIOR ADHESIVE

    MDR report key: 19751141 · Received July 16, 2024

    Report

    Report Number
    1419341-2024-00006
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 19, 2024
    Report Date
    October 30, 2025
    Manufacturer
    LEICA BIOSYSTEMS
    Product Code
    KES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY REVIEW WAS COMPLETED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES ASSOCIATED WITH THIS LOT. TRENDING ANALYSIS REPORTED NO OTHER RELATED OCCURRENCE OF THIS ISSUE FOR THIS PRODUCT LOT. QUALITY CONTROL TESTING WAS COMPLETE AND PASSED. RETAIN TESTING WAS COMPLETE AND PASSED. THERE IS NO DATA TO CONFIRM MANUFACTURING DEVIATION. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 19 JUN 2024 THE CUSTOMER REPORTED ABOUT HALF OF THE SLIDE WHITE APEX SUPERIOR ADHESIVE, P/N 3800080, LOT 111523-1 WERE NOT STICKY CAUSING ISSUE WITH PICKING UP THE RESEARCH TISSUE (BRAIN, LIVER, LUNG, SKIN ETC.) IN THE WATER BATH AND TISSUE FALLING OFF DURING ROUTINE H&E STAINING. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507125 SLIDE WHITE APEX SUPERIOR ADHESIVE COVERSLIPS, MICROSCOPE SLIDE KES LEICA BIOSYSTEMS SLIDE WHITE APEX SUPERIOR ADHESIVE 111523-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown