BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROWAVE

    MDR report key: 3244969 · Received January 28, 2013

    Report

    Report Number
    2954354-2013-00003
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CORNEAL EYE INJURY, NOT PERMANENT TO THE DEVICE OPERATOR. NO PT INJURY. THE DEVICE OPERATOR STATED THAT DURING ONE OF THE PULSES OF LIGHT ENERGY THAT WAS DELIVERED, THERE WAS A "BRIGHT FLASH OF LIGHT". THE DEVICE OPERATOR FELT A BURNING SENSATION IN THE LEFT EYE AFTER THE BRIGHT FLASH OF LIGHT. THE DEVICE OPERATOR REPORTED WEARING PROTECTIVE EYE GLASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38521 PROWAVE POWERED LASER SURGICAL INSTRUMENT GEX CUTERA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention