BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSENSE CRYOABLATION SYSTEM

    MDR report key: 18423128 · Received January 1, 2024

    Report

    Report Number
    3008797959-2024-00001
    Event Type
    Injury
    Date Received
    January 1, 2024
    Date of Event
    June 4, 2019
    Report Date
    January 1, 2024
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K183213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS DETAILED ABOVE.

    Description of Event or Problem · 0

    MILD EXPECTED SIDE EFFECT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467765 PROSENSE CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH ICECURE MEDICAL LTD. FAS3100000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other