BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XL60

    MDR report key: 273818 · Received April 14, 2000

    Report

    Report Number
    2914019-2000-00002
    Event Type
    Injury
    Date Received
    April 14, 2000
    Date of Event
    March 9, 2000
    Report Date
    March 17, 2000
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DR WAS PERFORMING BLEPHAROPLASTY SURGERY AND BURNED THE CORNEA OF FOUR PTS. ONE PT'S BURN RESULTED IN A SERIOUS INJURY. THE INJURY AFFECTS THE PT'S VISUAL ACUITY AND IS PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XL60 SURGICAL LASERS GEX COHERENT MEDICAL GROUP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other