BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALYUGIN RING SYSTEM

    MDR report key: 4093004 · Received September 5, 2014

    Report

    Report Number
    3019924-2014-00038
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 6, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HOC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED THAT THE RING HAD TO BE SECTIONED TO BE REMOVED FROM THE EYE HOWEVER THE RETURNED RING SHOWED NO EVIDENCE OF BEING USED IN SURGERY AND WAS WHOLE WITH A BROKEN GLUE JOINT. EFFORTS TO GET CLARIFICATION ON THIS INCIDENT HAVE BEEN UNFRUITFUL.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT WHEN THE SURGEON ATTEMPTED TO POSITION THE MALYUGIN RING THE RING BROKE AT THE JOINT. IT WAS REPORTED THAT THE SURGEON HAD TO SECTION THE RING TO REMOVE IT FROM THE EYE. THERE WAS NO REPORTED IMPACT TO THE PT AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545750 MALYUGIN RING SYSTEM IRIS CLIP, RETRACTOR HOC MICROSURGICAL TECHNOLOGY, INC. MAL-0002 059984

    Patients

    Seq Age Sex Outcome Treatment
    1