BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALYUGIN RING SYS

    MDR report key: 3820704 · Received May 1, 2014

    Report

    Report Number
    3019924-2014-00015
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HOC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RING WAS RETURNED IN A CONDITION THAT MADE EVALUATION VERY DIFFICULT TO ASCERTAIN WHY THE GLUE JOINT FAILED. THIS IS A VERY UNUSUAL INCIDENT.

    Description of Event or Problem · 1

    DURING RETRACTION OF A 6.25 MM MALYUGIN RING THE RING FRACTURED AT THE GLUE JOINT. THERE WAS NO IMPACT TO THE PT AND THE PROCEDURE WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262407 MALYUGIN RING SYS IRIS CLIP, RETRACTOR HOC MICROSURGICAL TECHNOLOGY, INC. MAL-0001 058008

    Patients

    Seq Age Sex Outcome Treatment
    1