BEUDAMED
    FDA Adverse Event Death Summary report: N

    CATHETER, CONTINUOUS FLUSH

    MDR report key: 10764108 · Received October 30, 2020

    Report

    Report Number
    2134265-2020-14986
    Event Type
    Death
    Date Received
    October 30, 2020
    Date of Event
    October 1, 2020
    Report Date
    October 30, 2020
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN: THEREFORE, DATE IS ESTIMATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEATH OCCURRED. AN EKOSONIC CATHETER WAS SELECTED FOR USE DURING A DEEP VEIN THROMBOSIS (DVT) PROCEDURE. AN UNKNOWN TIME POST-PROCEDURE, PATIENT PASSED AWAY. CAUSE OF DEATH IS UNKNOWN AT THIS TIME. NO DEVICE ISSUES WERE REPORTED. NO FURTHER INFORMATION IS CURRENTLY KNOWN. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226008 CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death