BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALYUGIN RING SYSTEM

    MDR report key: 4268513 · Received November 4, 2014

    Report

    Report Number
    3019924-2014-00048
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 30, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HOC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF BROKEN RINGS OR PATIENT IMPACT COULD NOT BE CONFIRMED WITH ANY OF THE FACILITY STAFF THAT THE DOCTOR REFERENCE IN HER REPORT.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT SHE HAD EXPERIENCED SEVERAL MALYUGIN RINGS HANGING ON THE IRIS UPON RETRACTION INTO THE CANNULA AS WELL AS OTHER RINGS THAT BROKE UPON RETRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706667 MALYUGIN RING SYSTEM IRIS CLIP RETRACTOR HOC MICROSURGICAL TECHNOLOGY, INC. MAL-0001-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other