BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRA CR4060 OPHTHALMIC CRYO PROBE

    MDR report key: 2022540 · Received February 16, 2011

    Report

    Report Number
    1218813-2010-00027
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    July 14, 2010
    Report Date
    February 11, 2011
    Manufacturer
    MIRA, INC.
    Product Code
    HPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROBE WAS PART OF RECALL. PROBE FOUND TO BE LEAKING AT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRA CR4060 OPHTHALMIC CRYO PROBE HPS MIRA, INC. CR4060 0506

    Patients

    Seq Age Sex Outcome Treatment
    1