BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETCAM SHUTTLE

    MDR report key: 2492801 · Received February 12, 2012

    Report

    Report Number
    2952489-2012-00001
    Event Type
    Malfunction
    Date Received
    February 12, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 26, 2012
    Manufacturer
    CLARITY MEDICAL SYSTEMS INC
    Product Code
    HKI
    PMA / PMN Number
    K090326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING THE INSTALLATION CLINICAL TRAINING AT UNIVERSITY OF (B)(6), CLARITY EMPLOYEE (B)(6) ENCOUNTERED A POSSIBLE MISLABELING OF A "RIGHT" EYE PHOTO AS "LEFT" EYE WHEN EXTRACTING STILLS FROM VIDEO RECORDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETCAM SHUTTLE OPHTHALMIC CAMERA HKI CLARITY MEDICAL SYSTEMS INC RETCAM SHUTTLE

    Patients

    Seq Age Sex Outcome Treatment
    1