BEUDAMED
    FDA Adverse Event Other Summary report: N

    RD-1200 RUBY LASER

    MDR report key: 49393 · Received November 8, 1996

    Report

    Report Number
    1223483-1996-00001
    Event Type
    Other
    Date Received
    November 8, 1996
    Date of Event
    October 8, 1996
    Report Date
    November 7, 1996
    Manufacturer
    SPECTRUM MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ERROR: DR USED LASER SYSTEM 694.3 WAVE LENGTH WITH EYEWEAR NOT RECOMMENDED PER DEVICE LABELING BY CO. EYEWEAR (FOR CYNOSURE DYE LASER) CHECKED. NO EVIDENCE OF LASER DAMAGE PER TESTING. DOCTOR + PT EXAMINED TO OPTICAL EXAM; RETINA, AMSER GRID, BOTH OK, NO INJURY. 100CT. INITIAL CALL DID NOT ALLEGE DEATH OR SERIOUS INJURY, ASKED IF THIS WAS OK? CO ADVISED TO HAVE DR, PT, AND EYEWEAR CHECKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RD-1200 RUBY LASER DERMATOLOGICAL LASER GEX SPECTRUM MEDICAL TECHNOLOGIES, INC. RD-1200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other