BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRA CR4010 OPHTHALMIC CRYO PROBE

    MDR report key: 2022560 · Received February 16, 2011

    Report

    Report Number
    1218813-2010-00024
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    June 17, 2010
    Report Date
    February 11, 2011
    Manufacturer
    MIRA, INC.
    Product Code
    HPS
    PMA / PMN Number
    K760686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROBE DOES NOT FREEZE TO THE SPECIFIED TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRA CR4010 OPHTHALMIC CRYO PROBE HPS MIRA, INC. CR4010 0300

    Patients

    Seq Age Sex Outcome Treatment
    1