BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFREEZE CRYOSPRAY SYSTEM

    MDR report key: 6210806 · Received December 28, 2016

    Report

    Report Number
    3010140265-2016-00005
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 28, 2016
    Manufacturer
    CSA MEDICAL, INC
    Product Code
    GEH
    UDI-DI
    00857068006006
    PMA / PMN Number
    K162695
    Removal / Correction Number
    Z-0941-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE AUDIBLE SOUND ASSOCIATED WITH THE TIMER WAS LOST DURING A PASSIVE VENTING (AIRWAY) CASE. THERE WAS NO REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861431 TRUFREEZE CRYOSPRAY SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL, INC CC3-01 00857068006006

    Patients

    Seq Age Sex Outcome Treatment
    1