BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHEATHES

    MDR report key: 10851627 · Received November 17, 2020

    Report

    Report Number
    10851627
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    August 19, 2020
    Report Date
    October 15, 2020
    Manufacturer
    SHEATHING TECHNOLOGIES, INC.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE PERFORMANCE OF AN ENDOCAVITAL PROCEDURE, WHEN TECHNICIAN REMOVED THE TRANSDUCER, IT WAS NOTICED THAT THE PROBE COVER WAS AT THE END OF THE PROBE. TRANSDUCER BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318683 SHEATHES TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX SHEATHING TECHNOLOGIES, INC. 10340 19-36

    Patients

    Seq Age Sex Outcome Treatment
    1 8030 DA