BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MST MALYUGIN RING

    MDR report key: 5048468 · Received September 1, 2015

    Report

    Report Number
    3019924-2015-00028
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    August 3, 2015
    Report Date
    September 1, 2015
    Manufacturer
    MICROSURGICAL TECHNOLOGY INC
    Product Code
    HOC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RING WAS RETURNED WITH A FRACTURED GLUE JOINT AND SHOWING SIGNS OF BEING SQUEEZED OR PINCHED DURING USE. THE PHYSICIAN INDICATED THAT HE WAS USING A METHOD OF REMOVAL THAT IS CONTRARY TO THE INSTRUCTIONS FOR USE. THE DOCTOR IMPLOYED THE USE OF THE OSHER MALYUGIN MANIPULATOR RATHER THAN THE INJECTOR TO REMOVE THE RING FROM THE EYE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT WHEN HE ATTEMPTED TO REMOVE THE MALYUGIN RING FROM THE PATIENT'S EYE WITH THE OSHER/MALYUGIN MANIPULATOR THE RING BROKE AT THE GLUE JOINT. THERE WAS NO IMPACT TO THE PATIENT AND THE RING WAS REMOVED FROM THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579049 MST MALYUGIN RING IRIS RETRACTOR CLIP HOC MICROSURGICAL TECHNOLOGY INC MAL-0002-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other