BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAPLUS ESMARK V1861 6X9 20/CS

    MDR report key: 21617920 · Received March 17, 2025

    Report

    Report Number
    21617920
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 26, 2025
    Report Date
    March 11, 2025
    Manufacturer
    HARTMANN USA INC.
    Product Code
    GAX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE STERILE PACKAGING FOR THE ESMARK LOOKS COMPROMISED. BOTH ENDS OF THE PACKAGING HAS A YELLOW DISCOLORATION. QUESTIONING IF THE PRODUCT IS STERILE. PRODUCT NEVER OPENED ONTO THE STERILE FIELD WE HAVE COME ACROSS SEVERAL OF THIS PRODUCT, ALL FROM THE SAME LOT #. WE ARE NOT USING UNTIL GET CLARIFICATION FROM THE COMPANY, AN EMAIL WAS SENT TO LEADER, WHO THEN EMAILED MEDLINE. EMAIL SENT [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284371 NOVAPLUS ESMARK V1861 6X9 20/CS TOURNIQUET, NONPNEUMATIC GAX HARTMANN USA INC. 18610073 X240302703

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown