BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRUSION CANNULA, 20 GAUGE

    MDR report key: 30095 · Received February 13, 1996

    Report

    Report Number
    MW1008326
    Event Type
    Injury
    Date Received
    February 13, 1996
    Date of Event
    February 8, 1996
    Report Date
    February 12, 1996
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING THE 20G EXTRUSION CANNULA IN THE ANTERIOR CHAMBER OF THE EYE. IT WAS NOTED THAT THE SILICONE TIP FROM THE EXTRUSION CANNULA HAD COME OFF AND WAS IN THE ANTERIOR CHAMBER AGAINST THE IRIS. MD REMOVED THE CANNULA AND THE SILICONE TIP IN ITS ENTIRETY. NO HARM WAS DONE TO THE EYE. THE CANNULA AND SILICONE TIP WERE PASSED OFF STERILE FIELD AFTER BEING CLEANSED WITH STERILE H2O.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRUSION CANNULA, 20 GAUGE OPHTHALMIC CANNULA HMX SYNERGETICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention