BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTASEAL

    MDR report key: 11805591 · Received May 11, 2021

    Report

    Report Number
    11805591
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 5, 2021
    Report Date
    April 29, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    MZM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    WHILE TRYING TO APPLY THE VISTASEAL¿ FIBRIN SEALANT (HUMAN), 4ML, THE VISTASEAL CAME OUT BETWEEN THE APPLICATOR AND THE DEVICE ITSELF. A SECOND DEVICE WAS OPENED AND USED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    WHILE TRYING TO APPLY THE VISTASEAL¿ FIBRIN SEALANT (HUMAN), 4ML, THE VISTASEAL CAME OUT BETWEEN THE APPLICATOR AND THE DEVICE ITSELF. A SECOND DEVICE WAS OPENED AND USED DURING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701596 VISTASEAL FIBRIN SEALANT PREPARATION DEVICE MZM ETHICON INC. A4YBE00051

    Patients

    Seq Age Sex Outcome Treatment
    1 13505 DA