BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE PORTIV

    MDR report key: 23136633 · Received September 24, 2025

    Report

    Report Number
    MW5176520
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 13, 2025
    Report Date
    September 19, 2025
    Manufacturer
    ADHEZION BIOMEDICAL /H.B. FULLER MEDICAL ADHESIVE TECHNOLOGIES, LLC
    Product Code
    NZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ARTERIAL LINES DAMPENING AFTER THE APPLICATION OF SECURE PORTIV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2394089 SECURE PORTIV SEALANT, MICROBIAL NZP ADHEZION BIOMEDICAL /H.B. FULLER MEDICAL ADHESIVE TECHNOLOGIES, LLC 240132

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male