BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTASEAL

    MDR report key: 12074840 · Received June 28, 2021

    Report

    Report Number
    12074840
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 10, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    MZM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VISTASEAL DID NOT THAW AFTER REMOVAL FROM TRAC CORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972231 VISTASEAL FIBRIN SEALANT PREPARATION DEVICE MZM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA