BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MST MALYUGIN RING SYSTEM

    MDR report key: 6969603 · Received October 23, 2017

    Report

    Report Number
    3019924-2017-00019
    Event Type
    Injury
    Date Received
    October 23, 2017
    Report Date
    October 20, 2017
    Manufacturer
    MICROSURGICAL TECHNOLOGY INC
    Product Code
    HOC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON REPORTED THAT THE PATIENT HAD PREEXISTING CONDITIONS, SYNECHIAE, AND THOUGHT THAT THE IRIS HAD SWOLLEN AS A RESULT OF THIS CONDITION AFTER THE MALYUGIN RING HAD BEEN INSERTED. THERE WAS NO FURTHER IMPACT TO THE PATIENT AND THE PROCEDURE WAS COMPLETED AS PLANNED.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT UPON REMOVAL OF THE MALYUGIN RING THE LEFT SCROLL WAS TIGHT AND DAMAGED THE IRIS. PATIENT WAS REPORTED TO BE DOING FINE POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749532 MST MALYUGIN RING SYSTEM CLIP IRIS RETRACTOR HOC MICROSURGICAL TECHNOLOGY INC MAL-0001-1 074114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other