BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIDE WHITE APEX SUPERIOR ADHESIVE

    MDR report key: 13385416 · Received January 28, 2022

    Report

    Report Number
    1419341-2022-00001
    Event Type
    Injury
    Date Received
    January 28, 2022
    Date of Event
    January 7, 2022
    Report Date
    March 21, 2022
    Product Code
    KEW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY REVIEW WAS COMPLETED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES ASSOCIATED WITH THIS LOT. QUALITY CONTROL TESTING WAS COMPLETE AND PASSED. ISSUE IS CURRENTLY BEING INVESTIGATED. ADDITIONAL INFORMATION OR INVESTIGATION RESULTS WILL BE SUBMITTED PENDING INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 0

    QUALITY CONTROL TESTING WAS COMPLETE AND PASSED THE RETURNED SLIDE WHITE APEX SUPERIOR ADHESIVE, P/N 3800080, LOT 121321-1. MULTIPLE NONSEQUENTIAL SLIDES WERE PULLED FROM EACH BOX AND SKIN SECTIONS WERE CUT AT THREE MICRONS AND PICKED UP ONTO THE SLIDES. THE SLIDES WERE PROCESSED ON THE LEICA BOND-III. ALL SLIDES WERE RUN ACCORDING TO OUR SLIDE ADHESION TEST PROCEDURE AND THE STAINING PROCEDURE RAN TO COMPLETION WITHOUT ERROR. THE SLIDES WERE REMOVED, COVERSPIPPED, AND EXAMINED. ALL SLIDES SHOWED COMPLETE TISSUE SECTIONS, ALL WERE WELL STAINED, AND ALL SHOWED CONSISTENT MICROSCOPIC DETAIL. THERE WAS NO TISSUE LOSS OR FLAKING SEEN ON ANY OF THE SLIDES. THE ISSUE WAS NOT CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2022 THE CUSTOMER EXPERIENCED TISSUE LOSS OF SKIN THAT WAS CUT AT 3 MICRONS ON ONE (1) OF THE SLIDE WHITE APEX SUPERIOR ADHESIVE, P/N 3800080, LOT 121321-1. THE TISSUE LOSS WAS FOUND DURING STAINING WITH IMMUNOHISTOCHEMISTRY ON A BOND INSTRUMENT. RE-BIOPSY OF THE PATIENT WAS NECESSARY FOR DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843664 SLIDE WHITE APEX SUPERIOR ADHESIVE SLIDE WHITE APEX SUPERIOR ADHESIVE KEW NA 121321-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other