BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFREEZE

    MDR report key: 12202304 · Received July 21, 2021

    Report

    Report Number
    12202304
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 25, 2021
    Report Date
    July 2, 2021
    Manufacturer
    CSA MEDICAL, INC.
    Product Code
    GEH
    UDI-DI
    00857068006105
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER USED FOR THE ABLATION BROKE AFTER THE 2ND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100295 TRUFREEZE UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL, INC. 20-00184 0526 00857068006105

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA