BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC KIT 135CM 30CM TZ

    MDR report key: 11879213 · Received May 25, 2021

    Report

    Report Number
    2134265-2021-06692
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    May 1, 2021
    Report Date
    May 25, 2021
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K182324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE WAS NOT REPORTED AND APPROXIMATED (B)(6) 2021.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ULTRA-SONIC CORE (USC/MSD) BROKE. DURING THE USE OF AN EKOSONIC KIT 135CM 30CM TZ CATHETER, THE WIRE INSIDE THE CATHETER BROKE. THERE WAS NO HARM TO THE PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777341 EKOSONIC KIT 135CM 30CM TZ CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION 500-56130

    Patients

    Seq Age Sex Outcome Treatment
    1