BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 17037755 · Received June 1, 2023

    Report

    Report Number
    17037755
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    May 5, 2023
    Report Date
    May 23, 2023
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BROKEN CERENE, PACKAGE RETURNED TO SURGICAL SUPPLIES; BROKEN BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297142 CERENE CRYOTHERAPY DEVICE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 101009375

    Patients

    Seq Age Sex Outcome Treatment
    1 17885 DA Female