BEUDAMED
    FDA Adverse Event Summary report: N

    LASER ARGON 532

    MDR report key: 3052793 · Received April 5, 2013

    Report

    Report Number
    MW5029693
    Date Received
    April 5, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    UNK
    Product Code
    GEX
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN, WHILE USING LASER INDIRECT OPHTHALMOSCOPE, NOTICED AN ODD FLASHBACK WHILE GETTING READY TO PERFORM A LASER SERVICE ON A PT. THERE WAS NO PT HARM AS IT AFFECTED THE MD ONLY. PHYSICIAN HAD EYE EXAM POST PROCEDURE. LASER TAKEN OUT OF SERVICE AND SEQUESTERED-AWAITING VENDOR EVAL. DURATION: 100MSEC. ON (B)(6) 2013 LASER MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139912 LASER ARGON 532 ARGON LASER 240 MW GEX UNK 532 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR