BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSESNE CRYOPROBE

    MDR report key: 22892917 · Received August 26, 2025

    Report

    Report Number
    3008797959-2025-00008
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    July 30, 2025
    Report Date
    August 26, 2025
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    UDI-DI
    07290015487085
    PMA / PMN Number
    K183213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    EXPECTED SIDE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2723411 PROSESNE CRYOPROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH ICECURE MEDICAL LTD. FAP7410000 20210926 07290015487085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other