BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRA CR4000 OPHTHALMIC CRYO UNIT

    MDR report key: 1910851 · Received November 23, 2010

    Report

    Report Number
    1218813-2010-00016
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    June 29, 2010
    Report Date
    November 19, 2010
    Manufacturer
    MIRA, INC.
    Product Code
    GEH
    PMA / PMN Number
    K760686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EXCESSIVE LEAKING FROM CRYO PROBE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRA CR4000 OPHTHALMIC CRYO UNIT GEH MIRA, INC. CR4010 0308

    Patients

    Seq Age Sex Outcome Treatment
    1