BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAGUIDECTR

    MDR report key: 22643139 · Received July 29, 2025

    Report

    Report Number
    3013479847-2025-00002
    Event Type
    Injury
    Date Received
    July 29, 2025
    Date of Event
    November 1, 2025
    Report Date
    July 22, 2025
    Manufacturer
    SONEX HEALTH
    Product Code
    LXH
    UDI-DI
    00860002094700
    PMA / PMN Number
    K192873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE OF THE EVENT IN SECTION B3 OF THIS REPORT WAS SELECTED AS 11/01/2025 TO REFLECT THAT THE EVENT OCCURRED IN NOVEMBER 2025. THE EXACT DATE OF THE EVENT IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, THE LOT NUMBER WAS NOT REPORTED AND THEREFORE A REVIEW OF DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. NERVE INJURY IS REFERENCED IN THE ULTRAGUIDECTR INSTRUCTIONS FOR USE AS A POSSIBLE COMPLICATION. NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 0

    ACCORDING TO INFORMATION OBTAINED FROM THE OPERATING SURGEON, A CTR-US (CARPAL TUNNEL RELEASE USING ULTRASOUND GUIDANCE) WAS PERFORMED IN (B)(6) 2024 FOR SEVERE CTS (CARPAL TUNNEL SYNDROME), INCLUDING PROXIMALLY RADIATING PAIN. THE PROCEDURE WAS UNEVENTFUL WITH NO DEVICE MALFUNCTION. TWO WEEKS POST-OPERATIVELY, THE CTS SYMPTOMS HAD COMPLETELY RESOLVED. HOWEVER, THE PATIENT REPORTED NEW NUMBNESS IN THE 3RD WEBSPACE. THE NUMBNESS PERSISTED AND AN MRI IN (B)(6) 2025 DEMONSTRATED POST-OPERATIVE CHANGES BUT NO OTHER ABNORMALITIES. THE PATIENT EVENTUALLY DEVELOPED SOME IRRITATIVE SYMPTOMS (PARESTHESIAS) ASSOCIATED WITH THE NUMBNESS. AN EXPLORATION USING AN OPEN CARPAL TUNNEL RELEASE APPROACH WAS PERFORMED IN (B)(6) 2025. FOCAL SWELLING (NOTED AS A "KNOT") WAS NOTED, POTENTIALLY INDICATIVE OF A NEUROMA IN CONTINUITY. HOWEVER, THERE WAS NO CLEAR SIGN OF INJURY. THE PHYSICIAN EXCISED THE ENLARGED NERVE SEGMENT AND PERFORMED A CONNECTOR ASSISTED NERVE REPAIR. IN THE EARLY POST-OPERATIVE PERIOD, THE PATIENT'S PARESTHESIAS HAD ALREADY RESOLVED, THOUGH SHE CONTINUED TO HAVE NUMBNESS IN THE THIRD INTERSPACE. THE PHYSICIAN PLANS TO FOLLOW THE PATIENT AND ANTICIPATES SOME RECOVERY OF SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411853 ULTRAGUIDECTR CARPAL TUNNEL RELEASE SYSTEM LXH SONEX HEALTH 600112-001 00860002094700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention