BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL TC ELECTRODE

    MDR report key: 6457434 · Received April 4, 2017

    Report

    Report Number
    3006630150-2017-01298
    Event Type
    Malfunction
    Date Received
    April 4, 2017
    Date of Event
    March 6, 2017
    Report Date
    March 6, 2017
    Manufacturer
    COSMAN MEDICAL
    Product Code
    LGW
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: NA.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: TCN-10 LOT #: 121816, 020916 AND 111516 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: TCN-10 LOT #: 021816, 020916 AND 111516 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM DEVICE ANALYSIS INDICATED THAT THE COMPLAINT WAS NOT CONFIRMED, HOWEVER, THE ELECTRODES FAILED VISUAL INSPECTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE GLUE INSIDE THE HUB OF THE ELECTRODE ERODED AND CAUSED BLOOD AND FLUIDS TO SEEP IN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE GLUE INSIDE THE HUB OF THE ELECTRODE ERODED AND CAUSED BLOOD AND FLUIDS TO SEEP IN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE GLUE INSIDE THE HUB OF THE ELECTRODE ERODED AND CAUSED BLOOD AND FLUIDS TO SEEP IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240791 NITINOL TC ELECTRODE ELECTRODE LGW COSMAN MEDICAL TCN-10 021916

    Patients

    Seq Age Sex Outcome Treatment
    1