BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER

    MDR report key: 19572803 · Received June 20, 2024

    Report

    Report Number
    3008797959-2024-00008
    Event Type
    Injury
    Date Received
    June 20, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 20, 2024
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GDF
    PMA / PMN Number
    K183213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    EXPECTED SIDE EFFECT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762796 INTRODUCER GUIDE, NEEDLE, SURGICAL GDF ICECURE MEDICAL LTD. FAC9000000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization