BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALYUGIN RING

    MDR report key: 1939739 · Received December 9, 2010

    Report

    Report Number
    1939739
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 9, 2010
    Manufacturer
    MICRO SURGICAL TECHNOLOGY
    Product Code
    HNQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE MALYUGIN RING WAS DEPLOYED OUT OF THE INSERTER. IT WAS NOTED BY THE SURGEON THAT TWO OF THE FOUR DIAMOND SHAPED EDGES HAD KINKS WHICH CAUSED THE RING TO BECOME TOO TIGHT ON THE PATIENT'S IRIS. THE SURGEON REMOVED THE RING WITHOUT HARM TO THE PATIENT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALYUGIN RING PUPIL EXPANSION DEVICE HNQ MICRO SURGICAL TECHNOLOGY * 038069

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR