BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVED CANNULA

    MDR report key: 3820193 · Received April 10, 2014

    Report

    Report Number
    1932402-2014-00003
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 10, 2014
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WANTED TO PERFORM A SUTURE-LESS 25 GAUGE VITRECTOMY, BUT THE CANNULA INABILITY TO BE RETAINED DURING INSTRUMENT EXTRACTION RESULTED IN LARGER WOUNDS REQUIRING SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216551 VALVED CANNULA CANNULA HMX SYNERGETICS, INC. 65025E M300290

    Patients

    Seq Age Sex Outcome Treatment
    1