BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 17466054 · Received August 4, 2023

    Report

    Report Number
    3012018285-2023-00003
    Event Type
    Injury
    Date Received
    August 4, 2023
    Date of Event
    January 20, 2023
    Report Date
    August 4, 2023
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE DISCARDED AND NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    THE PHYSICIAN REPORTED SHE PERFORMED ENDOMETRIAL ABLATION IN MID-JANUARY USING THE CERENE DEVICE. THERE WERE NO PROBLEMS DURING THE PROCEDURE ALTHOUGH, NOTABLY, THE PATIENT HAD A THICK ENDOMETRIUM (20MM) ONE MONTH PRIOR TO THE TREATMENT DATE, REGARDLESS OF USING PROGESTIN (PROMETRIUM) TO THIN THE ENDOMETRIUM AND CONTROL BLEEDING. FOUR DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED A LOW-GRADE FEVER, HEAVY BLEEDING WITH CLOTS, AND INCREASED PELVIC PAIN. THE PATIENT WAS EVALUATED AND ADMITTED TO THE HOSPITAL FOR PRESUMED ENDOMETRITIS, WHERE SHE SPENT 2 DAYS WITH IV ANTIBIOTIC TREATMENT BEFORE BEING DISCHARGED HOME WITH ORAL ANTIBIOTICS. ONCE BLEEDING STOPPED, THE PATIENT WAS FEELING BETTER. UPON DISCUSSION WITH THE PHYSICIAN, SHE STATED SHE FELT THAT THE PATIENT'S PAIN AND LOW-GRADE FEVER WERE MORE LIKELY RELATED TO THE HEAVY BLEEDING AND CLOTS, WHICH CAUSED THE INCREASED PELVIC PAIN VERSUS ENDOMETRITIS, BUT ERRED ON THE SIDE OF CAUTION AND TREATED THE PATIENT FOR ENDOMETRITIS. THE PATIENT WAS SEEN ONE-MONTH POST-OP (ON (B)(6) 2023) AND IS DOING WELL AND AWAITING HER NEXT MENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890989 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R