BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIKON OCULAR

    MDR report key: 415865 · Received September 5, 2002

    Report

    Report Number
    MW1026107
    Event Type
    Injury
    Date Received
    September 5, 2002
    Date of Event
    February 19, 2002
    Report Date
    September 5, 2002
    Manufacturer
    NIKON
    Product Code
    MYC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR ON 01/02/03: THE MEDICAL DEVICE (INDIRECT OPHTHALMOSCOPE) IDENTIFIED IN THE ABOVE-IDENTIFIED MEDICAL DEVICE REPORT WAS NOT MANUFACTURED BY NIKON INC. THE DEVICE WAS MANUFACTURED BY PROPPER MANUFACTURING CO., INC., 36-04 SKILLMAN AVE, LONG ISLAND CITY, NEW YORK 11101.

    Description of Event or Problem · 1

    PT TO UNDERGO LASER PHOTO COAGULATION OF THE RETINA, RELATED TO NEOVASCULAR GLAUCOMA. PHYSICIAN SELECTED LENS AND PERFORMED A PAN RETINAL PHOTOCOAGULATION. PROCEDURE PERFORMED ON PROPER EYE BUT WRONG SITE. PT SUSTAINED A SCAR TO THE MACULA, PRESSURE NORMALIZED, SIGHT NOT IMPROVED. PT INFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIKON OCULAR INDIRECT OPHTHALMASCOPE MYC NIKON * *
    2 VOLK INDIRECT OPHTHALMASCOPE MYC VOLK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention