BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    37-5 FLUID MANAGEMENT SYSTEM

    MDR report key: 6045673 · Received October 20, 2016

    Report

    Report Number
    6045673
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    June 28, 2016
    Report Date
    July 19, 2016
    Manufacturer
    THERMEDX, LLC
    Product Code
    HIG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HYSTEROSCOPY LUER LOCK TUBING SET, THERMEDX CATALOG NUMBER LL0002; INFLOW TUBING CONNECTION BROKE OFF. OPENED NEW KIT AND REPLACED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697061 37-5 FLUID MANAGEMENT SYSTEM INSUFFLATOR, HYSTEROSCOPIC HIG THERMEDX, LLC 1532017

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR