BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOND PLUS SLIDES

    MDR report key: 23362817 · Received October 22, 2025

    Report

    Report Number
    1419341-2025-00035
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 22, 2025
    Manufacturer
    ERIE SCIENTIFIC COMPANY
    Product Code
    KEW
    UDI-DI
    20849832023108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED TISSUE SECTION WERE FALLING OFF OF BOND PLUS SLIDES, P/N S21.2113.A, LOT 060325-9. NO ADVERSE EVENTS WERE REPORTED. TRENDING ANALYSIS FROM 30 SEP 2024 TO 20 SEP 2025 REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. THE PRODUCT HISTORY WAS REVIEWED AND NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING RECORD FOR THIS PRODUCT THAT WOULD CAUSE OR CONTRIBUTE TO THE PROBLEM REPORTED IN THIS COMPLAINT AND THERE HAVE BEEN NO PRIOR COMPLAINTS FOR THIS SAME BATCH/LOT NUMBER. THE ROOT CAUSE FOR THE "SECTION DROPPING OFF FROM THE SLIDE" 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 A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 24 SEPTEMBER 2025, LEICA BIOSYSTEMS RECEIVED A COMPLAINT DETAILING "SECTION DROPPING OFF FROM THE SLIDE". ON 30 SEPTEMBER 2025, THE LEICA BIOSYSTEMS CUSTOMER SERVICE EXECUTIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION "¿THE ISSUE IS SECTIONS FALLING OFF THEIR BOND PLUS SLIDE". AS OF 22 OCTOBER 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. ALTHOUGH THE INFORMATION AVAILABLE INDICATES THAT THERE HAS BEEN NO ADVERSE IMPACT REPORTED TO THE MANUFACTURER IN ASSOCIATION WITH THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT, THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT HAVE PREVIOUSLY RESULTED IN SERIOUS INJURY AND ARE CONSIDERED A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228729 BOND PLUS SLIDES SLIDES, MICROSCOPE KEW ERIE SCIENTIFIC COMPANY BOND PLUS SLIDES 060325-9 20849832023108

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown