BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR, CAUTERY CORD

    MDR report key: 5456502 · Received February 24, 2016

    Report

    Report Number
    5456502
    Event Type
    Malfunction
    Date Received
    February 24, 2016
    Date of Event
    December 7, 2015
    Report Date
    January 19, 2016
    Manufacturer
    STRADIS HEALTHCARE, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CORD WAS DIFFICULT TO PLUG IN; WITH PRESSURE IT LOOSENED AND DOES NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112951 BIPOLAR, CAUTERY CORD GEI STRADIS HEALTHCARE, INC. 4530 115317

    Patients

    Seq Age Sex Outcome Treatment
    1