BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTIMA SE

    MDR report key: 86190 · Received April 17, 1997

    Report

    Report Number
    2914019-1997-00012
    Event Type
    Other
    Date Received
    April 17, 1997
    Date of Event
    February 11, 1997
    Report Date
    April 17, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    POSSIBLE FLASHBACK REPORTED. USER ERROR WITH LASERLINK. IMPROPER SET UP OF THE DEVICE BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMA SE OPHTHALMIC LASER HQF COHERENT MEDICAL LASER GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *