BEUDAMED
    FDA Adverse Event Other Summary report: N

    MST MALYUGIN RING SYSTEM

    MDR report key: 2474086 · Received February 24, 2012

    Report

    Report Number
    3019924-2012-00003
    Event Type
    Other
    Date Received
    February 24, 2012
    Report Date
    February 24, 2012
    Manufacturer
    MICROSURGICAL TECHNOLOGY INC
    Product Code
    HNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON NOTED THAT HE OBSERVED A SILVERY OR CARBON LIKE PARTICLES AROUND THE INCISION AFTER REMOVING THE INJECTOR. THE PARTICLES WERE TOO SMALL TO REMOVE AND THERE HAS BEEN NO PT COMPLICATIONS.

    Description of Event or Problem · 1

    THE SURGEON REPORTED TO A SALES REP THAT HE HAD BEEN OBSERVING SPORADIC INSTANCES OF MICROSCOPIC METAL FLAKES COMING FROM THE CANNULA OF THE INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MST MALYUGIN RING SYSTEM IRIS EXPANDER HNI MICROSURGICAL TECHNOLOGY INC MAL-0001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other