BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 17792701 · Received September 21, 2023

    Report

    Report Number
    3012018285-2023-00004
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 21, 2023
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    PMA / PMN Number
    P180032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    POST-PROCEDURAL PAIN/DISCOMFORT IS A KNOWN ADVERSE EVENT, WHICH IS DOCUMENTED IN THE LABELING AS PELVIC PAIN, UTERINE CRAMPS, UTERINE TENDERNESS, POSTOPERATIVE CRAMPING, AND ABDOMINAL PAIN AND/OR BLOATING.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED WITH THE CERENE CRYOTHERAPY DEVICE ON (B)(6), 2023. THE PROCEDURE WAS NORMAL AND NOTHING UNUSUAL OCCURED. THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION. ON DAY 3 POST-PROCEDURE, THE PATIENT BEGAN TO EXPERIENCE "PRESSURE" DESCRIBED AT A LEVEL OF 8 (ON A 0-10 SCALE). THERE WERE NO SIGNS OR SYMPTOMS OF INFECTION. THE PHYSICIAN REPORTED THAT THE PATIENT HAD NOT TAKEN ANY PAIN MEDICATION SINCE THE PROCEDURE AND REFUSED MEDICATION. ON (B)(6), THE PHYSICIAN REPORTED THAT SHE HAD ORDERED AN ULTRASOUND OF THE PELVIS AND IT WAS NORMAL; THE PATIENT IS DOING BETTER AND NO FURTHER WORK UP OR FOLLOW UP IS NEEDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2036043 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 102887363

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention