BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAGUIDECTR

    MDR report key: 21163931 · Received January 15, 2025

    Report

    Report Number
    3013479847-2025-00001
    Event Type
    Injury
    Date Received
    January 15, 2025
    Date of Event
    December 2, 2024
    Report Date
    January 15, 2025
    Manufacturer
    SONEX HEALTH
    Product Code
    LXH
    UDI-DI
    00860002094700
    PMA / PMN Number
    K192873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE NOTED RELATED TO THIS EVENT. VESSEL INJURY IS REFERENCED IN THE ULTRAGUIDECTR INSTRUCTIONS FOR USE AS A POSSIBLE COMPLICATION. NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 0

    AFTER PERFORMING AN IN-OFFICE CTR PROCEDURE USING ULTRASOUND GUIDANCE, THE PHYSICIAN NOTED GREATER THAN NORMAL BLEEDING FROM THE WOUND. THE BLEEDING WAS CONTROLLED AND THE INCISION CLOSED. THE PATIENT LATER RETURNED TO THE PHYSICIAN'S OFFICE COMPLAINING OF PAIN AND NUMBNESS IN THE SMALL FINGER. THE SURGEON PERFORMED SURGERY TO REPAIR THE ULNAR ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791745 ULTRAGUIDECTR CARPAL TUNNEL RELEASE SYSTEM LXH SONEX HEALTH 600112-001 64068 00860002094700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention