BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITE NON CLIP PERMASLIDE PLUS ADHESIVE

    MDR report key: 22333392 · Received June 25, 2025

    Report

    Report Number
    1419341-2025-00029
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 29, 2025
    Report Date
    July 11, 2025
    Manufacturer
    LEICA BIOSYSTEMS RICHMOND INC.
    Product Code
    KEW
    UDI-DI
    20849832023153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED LIVER TISSUE FALLING OFF OF WHITE NON CLIP PERMASLIDE PLUS ADHESIVE, P/N 3800455, LOT 4900075392. NO ADVERSE EVENTS WERE REPORTED. TRENDING ANALYSIS FROM 13 JUN 2024 TO 13 JUN 2025 REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. THE PRODUCT HISTORY WAS REVIEWED AND DID NOT IDENTIFY ANY INFORMATION IN THE MANUFACTURING RECORD FOR THIS PRODUCT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PROBLEM REPORTED IN THIS COMPLAINT. AS MANUFACTURER INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS, THE ROOT CAUSE OF THIS EVENT HAS NOT YET BEEN DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER TESTING OF RETAIN SAMPLES WAS UNABLE TO REPLICATE THE "TISSUE FALL OFF" REPORTED BY THE CUSTOMER. THE ROOT CAUSE FOR THE "TISSUE FALL OFF" REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 29 MAY, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "WE JUST RECENTLY HAD SOME ISSUES WITH LIVERS, IT NOT A NORMAL THING BUT...TISSUE FALL OFF. WE OCCASIONALLY HAVE A SLIDE OR TWO ONCE A MONTH AT WORST. IN THIS CASE IT WAS CLOSER TO 20-30 SLIDES THAT WERE AFFECTED."ON 14 JUNE 2025, THE CUSTOMER ADVISED LEICA BIOSYSTEMS THAT THE TISSUE WAS NON-CLINICAL TISSUE AND ADDITIONAL TISSUE WAS AVAILABLE. NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537692 WHITE NON CLIP PERMASLIDE PLUS ADHESIVE SLIDES, MICROSCOPE KEW LEICA BIOSYSTEMS RICHMOND INC. WHITE NON CLIP PERMASLIDE PLUS ADHESIVE 4900075392 20849832023153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown