BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ILLUMINATOR

    MDR report key: 50004 · Received November 15, 1996

    Report

    Report Number
    MW1010272
    Event Type
    Malfunction
    Date Received
    November 15, 1996
    Date of Event
    October 29, 1996
    Report Date
    November 1, 1996
    Manufacturer
    INFINITECH, INC.
    Product Code
    HJM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING VITRECTOMY SURGERY OF LEFT EYE TWO (2) PIECES OF METAL SHAVINGS WERE VISIBLE WITHIN EYE. MAGNET UTILIZED TO REMOVE METAL. NO HARM TO PT EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO ILLUMINATOR ENDO ILLUMINATOR 20G HJM INFINITECH, INC. * 614106

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR