BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORNTON TRIPLE EDGE ARC KNIFE

    MDR report key: 22641 · Received January 26, 1995

    Report

    Report Number
    1932180-1995-00005
    Event Type
    Other
    Date Received
    January 26, 1995
    Date of Event
    November 15, 1994
    Report Date
    January 10, 1995
    Manufacturer
    LABORATORY INSTRUMENTS
    Product Code
    HNN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING RADIAL KERATOTOMY, THE EPHITIELIUM COULD BE SEEN COMING OUT OF ALL FOUR INCISIONS. THE PT SUFFERED CORNEAL ABRASION. THE PT'S EYE HEALED WITHOUT ADDITIONAL MEDICATION. PT SUFFERED ONLY MINOR ADDITIONAL DISCOMFORT.(NOTE: CONTACT REQUESTED INSPECTION OF FOOTPLACES OF THE DEVICE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORNTON TRIPLE EDGE ARC KNIFE DIAMOND KNIFE HNN LABORATORY INSTRUMENTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other