BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMAFLEX PLUS ADHESIVE SLIDES, WHITE

    MDR report key: 21947197 · Received May 1, 2025

    Report

    Report Number
    1419341-2025-00027
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    April 3, 2025
    Report Date
    May 30, 2025
    Manufacturer
    LEICA BIOSYSTEMS RICHMOND INC.
    Product Code
    KEW
    UDI-DI
    20849832023146
    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 IS FALLLNG [SIC] OFF THE SLIDES DURING IHC" REPORTED BY THE CUSTOMER. THE ROOT CAUSE FOR THE "TISSUE IS FALLLNG [SIC] OFF THE SLIDES DURING IHC" 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.

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY REVIEW WAS COMPLETED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES ASSOCIATED WITH THIS LOT. TRENDING ANALYSIS REPORTED NO (0) OTHER RELATED OCCURRENCE OF THIS ISSUE FOR THIS PRODUCT LOT. QUALITY CONTROL TESTING WAS COMPLETE AND PASSED. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 03 APRIL 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "TISSUE IS FALLING OFF THE SLIDES; 2ND SECTION FALLS OFF, OVEN IS USED 30 MIN, AFFECTS ONLY IHC, NOT ALL SECTIONS FALL OFF. NO IRRETRIEVABLE TISSUE LOSS WAS REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023143 PERMAFLEX PLUS ADHESIVE SLIDES, WHITE SLIDES, MICROSCOPE KEW LEICA BIOSYSTEMS RICHMOND INC. PERMAFLEX PLUS ADHESIVE SLIDES, WHITE 022525-1 20849832023146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown