BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURA XP

    MDR report key: 2033268 · Received March 24, 2011

    Report

    Report Number
    MW5019959
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 24, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE TESTING THE LASER ((B)(4) LASER) BEFORE USE, THE EYE FILTER FAILED TO ENGAGE, RESULTING IN THE LASER BEAM HITTING THE PHYSICIAN IN THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AURA XP LASER GEX AMERICAN MEDICAL SYSTEMS AMS KTP / 532 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention