BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMAFLEX PLUS ADHESIVE SLIDES, WHITE

    MDR report key: 22800219 · Received August 13, 2025

    Report

    Report Number
    1419341-2025-00032
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 16, 2025
    Report Date
    October 15, 2025
    Manufacturer
    LEICA BIOSYSTEMS RICHMOND INC.
    Product Code
    KEW
    UDI-DI
    20849832023146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE FOR THE "TISSUE FALL OFF" REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. ALTHOUGH THE INFORMATION AVAILABLE INDICATES THAT NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER, THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT HAVE PREVIOUSLY RESULTED IN SERIOUS INJURY. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED TISSUE FALLING OF PERMAFLEX PLUS ADHESIVE SLIDES, WHITE, P/N 3800014, LOT 090324-1 WHILE RUNNING STANDARD H&E. NO ADVERSE EVENTS WERE REPORTED. DEVICE HISTORY REVIEW WAS COMPLETED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES ASSOCIATED WITH THIS LOT. TRENDING ANALYSIS REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. QUALITY CONTROL TESTING WAS COMPLETE AND PASSED. 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.

    Description of Event or Problem · 0

    ON 16 JULY 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "CUSTOMER WAS HAVING ISSUES WITH TISSUE FALL OFF WITH STANDARD H&E." AS OF 13 AUGUST 2025, LEICA BIOSYSTEMS HAS NOT RECEIVED INFORMATION AS TO EITHER THE FINAL STATUS OF THE PATIENT TISSUE SAMPLES INVOLVED IN THIS EVENT OR THE PATIENT IMPACT/OUTCOME. 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
    79459 PERMAFLEX PLUS ADHESIVE SLIDES, WHITE SLIDES, MICROSCOPE KEW LEICA BIOSYSTEMS RICHMOND INC. PERMAFLEX PLUS ADHESIVE SLIDES, WHITE 090324-1 20849832023146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown