BEUDAMED
    FDA Adverse Event Other Summary report: N

    HGM

    MDR report key: 216744 · Received March 26, 1999

    Report

    Report Number
    1720381-1999-00004
    Event Type
    Other
    Date Received
    March 26, 1999
    Date of Event
    February 17, 1999
    Report Date
    February 17, 1999
    Manufacturer
    FISMA, INC.
    Product Code
    LQJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING PROCEDURE USING A ZEISS THIN SHUTTER MICROFILTER WITH AN ARGON LASER. PHYSICIAN NOTICED A MINIMAL AMOUNT OF GREEN LIGHT FLASHBACK. PHYSICIAN PUT ON GOGGLES AND COMPLETED THE PROCEDURE. USER FACILITY REPORTED THAT THERE WAS NO SIGNIFICANT EXPOSURE AND NO FOLLOW-UP DONE ON THEIR PART. THERE WAS NO INJURY TO PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGM ARGON MICROFILTER LQJ FISMA, INC. K10-A-K03-1-73 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other