BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONEX ULTRAGUIDE CTR

    MDR report key: 18573778 · Received January 23, 2024

    Report

    Report Number
    MW5150674
    Event Type
    Injury
    Date Received
    January 23, 2024
    Date of Event
    January 19, 2024
    Report Date
    January 20, 2024
    Manufacturer
    SONEX HEALTH, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING AN ULTRASOUND GUIDED CTR(CARDIOTHORACIC RATIO) SURGERY TO MY LEFT HAND, ONE OF THE BALLOONS (ON SIDES OF CUTTING DEVICE) FAILED TO DEFLATE WHILE INSIDE MY WRIST. I KNOW THIS BECAUSE THE SURGEON EXPLAINED IT TO ME AS IT HAPPENED. IT SEEMED AS IF HE HAD DIFFICULTY REMOVING THE DEVICE BECAUSE OF THIS. I BELIEVE IT WAS THE SONEX ULTRAGUIDE CTR DEVICE. SINCE IT OCCURRED YESTERDAY, I DO NOT KNOW WHAT THE POTENTIAL OUTCOME MAY BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056585 SONEX ULTRAGUIDE CTR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SONEX HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female