BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMAFLEX PLUS ADHESIVE SLIDES, WHITE

    MDR report key: 21990063 · Received May 8, 2025

    Report

    Report Number
    1419341-2025-00028
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 8, 2025
    Manufacturer
    LEICA BIOSYSTEMS RICHMOND INC.
    Product Code
    KEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER TESTING OF RETAIN SAMPLES WAS UNABLE TO REPLICATE THE "TISSUE FALLING OFF MY IHC SLIDES..." REPORTED BY THE CUSTOMER. THE ROOT CAUSE FOR THE "TISSUE FALLING OFF MY IHC SLIDES..." REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER TO DATE. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 09 APRIL 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "TISSUE FALLING OFF MY IHC SLIDES THAT GO ON THE BOND WITHIN THE LAST FEW DAYS/WEEKS. NOTHING HAS CHANGED. LEICA PERMAFLEX PLUS SLIDES THAT I RECENTLY RECEIVED. THIS IS THE MOST RECENT LOT." AS AT 08 MAY 2025, LEICA BIOSYSTEMS HAS NOT RECEIVED INFORMATION AS TO EITHER THE FINAL STATUS OF THE PATIENT SLIDES 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
    795540 PERMAFLEX PLUS ADHESIVE SLIDES, WHITE SLIDES, MICROSCOPE KEW LEICA BIOSYSTEMS RICHMOND INC. PERMAFLEX PLUS ADHESIVE SLIDES, WHITE 100824-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown