BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASTISOL

    MDR report key: 24291555 · Received February 9, 2026

    Report

    Report Number
    24291555
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 14, 2026
    Report Date
    January 29, 2026
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE SURGICAL FIRST ASSIST WAS ABOUT TO CLOSE THE WOUND. 4 MASTISOL CONTAINERS SHATTERED AND LEFT SHARDS OF GLASS ON THE MAYO STAND WHEN ATTEMPTING TO CLOSE THE OPEN WOUND. PER THE SCRUB TECHNICIAN, EVERY TIME THE FIRST ASSIST ATTEMPTED TO OPEN A CONTAINER, IT WOULD SHATTER. NO OTHER REPORTS OF THIS ISSUE HAVE OCCURRED. DID NOT REACH PATIENT. MD ORDERED A DIFFERENT BRAND OF GLUE TO BE USED FOR CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352039 MASTISOL TAPE AND BANDAGE, ADHESIVE KGX FERNDALE LABORATORIES, INC. 1 24144B

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female