BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMEDX HYSTEROSCOPY MACHINE

    MDR report key: 4645269 · Received March 26, 2015

    Report

    Report Number
    MW5041711
    Event Type
    Other
    Date Received
    March 26, 2015
    Date of Event
    December 5, 2014
    Report Date
    March 13, 2015
    Manufacturer
    THERMEDX, LLC.
    Product Code
    HIG
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING A HYSTEROSCOPIC MYOMECTOMY AND THE OPERATION ROOM NURSE ADDED A NEW BAG OF GLYCINE AND THE DEFICIT AMOUNT ON THE HYSTEROCOPY MACHINE IMMEDIATELY WENT FROM 280 TO 0. THE REPRESENTATIVE FOR THE MACHINE (WHICH WAS JUST PURCHASED) CAME IN ON (B)(6) /2014 AND CHECKED THE MACHINE. NO ISSUES WERE FOUND. THERE WERE NO INJURIES OR ISSUES WITH THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201849 THERMEDX HYSTEROSCOPY MACHINE HYSTEROSCOPY MACHINE HIG THERMEDX, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other