BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 18058330 · Received November 2, 2023

    Report

    Report Number
    3012018285-2023-00005
    Event Type
    Injury
    Date Received
    November 2, 2023
    Date of Event
    October 6, 2023
    Report Date
    November 2, 2023
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PREFERRED TERM FOR ADVERSE EVENT CLINICAL CODE WOULD BE "DIFFICULTY KEEPING EYES OPEN".

    Description of Event or Problem · 0

    THE PATIENT RECEIVED A COMPLETE ENDOMETRIAL ABLATION PROCEDURE WITH THE CERENE CRYOTHERAPY DEVICE AND WAS DISCHARGED HOME IN GOOD CONDITION. ONCE HOME, SHE EXPERIENCED NUMBNESS OF THE FACE AND COULD NOT KEEP HER EYES OPEN. THE PHYSICIAN ASKED HER TO RETURN TO THE CLINIC FOR EVALUATION. THE PHYSICIAN CALLED A TOXICOLOGIST AND CHANNEL MEDSYSTEMS MEDICAL AFFAIRS REPRESENTATIVE TO CONFER, AS HE WANTED TO KNOW IF EXPOSURE TO NITROUS OXIDE COULD BE A POSSIBLE CAUSE OF THE PATIENT'S SYMPTOMS. THE TOXICOLOGIST STATED THAT THE RISK OF AN ADVERSE REACTION TO NITROUS OXIDE EXPOSURE WAS EXTREMELY LOW. THE CHANNEL MEDSYSTEMS MEDICAL AFFAIRS REPRESENTATIVE FURTHER EXPLAINED THAT THE CERENE DEVICE IS A CLOSED SYSTEM WITH LINER INTEGRITY CHECKS BUILT INTO THE SOFTWARE OF THE DEVICE, THEREFORE DIRECT EXPOSURE TO NITROUS OXIDE WAS UNLIKELY. THE TOXICOLOGIST WAS MORE CONCERNED WITH ANY ORAL, TOPICAL, OR INJECTED MEDICATIONS THAT WERE USED. THE PHYSICIAN STATED THAT THE PATIENT "MAYBE" TOOK A MOTRIN BUT NOTHING ELSE. THE PHYSICIAN REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM THE SAME DAY. SHE WAS ADMINISTERED MOTRIN FOR UTERINE CRAMPS AND WAS FINE WITHIN ONE HOUR OF ARRIVING. HER FACIAL SYMPTOMS AND EXTREMITY NUMBNESS (WHICH WAS NOT REPORTED BY THE PHYSICIAN INITIALLY) COMPLETELY WENT AWAY. THE PHYSICIAN STATED THAT HE BELIEVED THE PATIENT'S SYMPTOMS WERE CAUSED BY AN ATYPICAL PANIC ATTACK TRIGGERED BY POST-PROCEDURE CRAMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927694 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 103151029 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention