BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 19647466 · Received June 28, 2024

    Report

    Report Number
    MW5156848
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    June 25, 2024
    Report Date
    June 26, 2024
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CERENE CRYOTHERAPY DEVICE MALFUNCTIONED, SHOWED ERROR CODE 207, CERENE LOT #: 103151030. NO HARM TO THE PATIENT, DEVICE REMOVED AND BAGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684723 CERENE CRYOTHERAPY DEVICE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 1031511030

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female