BEUDAMED
    FDA Adverse Event Other Summary report: N

    MST MALYUGIN RING SYSTEM

    MDR report key: 2074632 · Received April 23, 2011

    Report

    Report Number
    3019924-2011-00005
    Event Type
    Other
    Date Received
    April 23, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 23, 2011
    Manufacturer
    MICROSURGICAL TECHNOLOGY INC
    Product Code
    HOC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS BEEN UNABLE TO CONTACT THE FACILITY CONCERNING THE EVENT. INITIAL ADVICE VIA EMAIL TO THE FACILITY WAS TO REMOVE THE RING.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE SURGEON WAS NOT ABLE TO REMOVE THE RING AFTER THE PROCEDURE AND THAT THE RING HAD FALLEN BEHIND THE IRIS. THE SURGEON REPORTEDLY LEFT THE RING IN THE EYE IN THE ORIGINAL SURGERY. IT WAS NOT KNOWN AT THIS TIME WHETHER THE RING WAS ULTIMATELY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MST MALYUGIN RING SYSTEM IRIS CLIP HOC MICROSURGICAL TECHNOLOGY INC MAL-0001 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention