BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX SUPERIOR ADHESIVE SLIDE - WHITE

    MDR report key: 21659857 · Received March 20, 2025

    Report

    Report Number
    1419341-2025-00025
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    February 20, 2025
    Report Date
    June 1, 2025
    Manufacturer
    LEICA BIOSYSTEMS RICHMOND INC.
    Product Code
    KEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUBMISSION 1419341-2025-00025 FOLLOW-UP 1 WAS MISSING THE AWARENESS DATE IN SECTION G3/4. THE CORRECT DATE WAS 26 FEBRUARY 2025.

    Additional Manufacturer Narrative · 0

    MANUFACTURER TESTING OF RETAIN SAMPLES WAS ABLE TO REPLICATE THE "TISSUES DETACHMENTS" REPORTED BY THE CUSTOMER. THE ROOT CAUSE FOR THE "TISSUES DETACHMENTS" 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

    AS MANUFACTURER INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS, THE ROOT CAUSE OF THIS EVENT HAS NOT YET BEEN DETERMINED. RETAIN SAMPLES OF THE SUSPECT DEVICE ARE BEING TESTED AS THE DEVICE INVOLVED IN THIS EVENT ARE UNABLE TO BE TESTED.

    Description of Event or Problem · 0

    NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER.

    Description of Event or Problem · 0

    ON 20 FEBRUARY 2025, LEICA BIOSYSTEMS RECEIVED INFORMATION THAT "THE CUSTOMER REPORTED ALL TYPES OF TISSUE FALLING OFF OF APEX SUPERIOR ADHESIVE SLIDE - WHITE (1440), P/N: 3800080E, LOT: 4900073503." AS AT 20 MARCH 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
    337563 APEX SUPERIOR ADHESIVE SLIDE - WHITE SLIDES, MICROSCOPE KEW LEICA BIOSYSTEMS RICHMOND INC. APEX SUPERIOR ADHESIVE SLIDE - WHITE (1440) 4900073503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown