BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAGUIDECTR

    MDR report key: 17998348 · Received October 24, 2023

    Report

    Report Number
    3013479847-2023-00008
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    September 1, 2023
    Report Date
    October 24, 2023
    Manufacturer
    SONEX HEALTH
    Product Code
    LXH
    UDI-DI
    00860002094700
    PMA / PMN Number
    K192873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. INFECTION IS REFERENCED IN THE ULTRAGUIDECTR INSTRUCTIONS FOR USE AS A POSSIBLE COMPLICATION. NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 0

    THE PATIENT HAD RIGHT-HAND AND LEFT-HAND CARPAL TUNNEL RELEASE USING ULTRAGUIDECTR WITH ULTRASOUND GUIDANCE. 11 DAYS AFTER SURGERY, PATIENT HAD ONSET OF INCREASING PAIN, STIFFNESS AND SWELLING WITH CLEAR FLUID DISCHARGE FROM RIGHT HAND INCISION SITE ONLY. PATIENT STATES THE LEFT HAND IS HEALING WELL WITHOUT ISSUES. THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT FOR EVALUATION CONCERNING FLEXOR TENOSYNOVITIS/INFECTIOUS COMPLICATION OF RIGHT HAND. NO FEVER OR CHILLS. THE PATIENT HAD SUPERFICIAL ABRASION TO RIGHT WRIST 3-4 DAYS PRIOR BY MOVING WOOD. PATIENT REPORTED THAT RIGHT HAND WAS HEALING WELL BUT WOKE UP WITH THE NEW SYMPTOMS: ACUTE ONSET OF SIGNIFICANT PAIN TO RIGHT WRIST AND PALMAR ASPECT OF RIGHT HAND ALONG FOURTH OR FIFTH FLEXOR SHEATH. THE POSSIBILITY THAT THE INFECTIOUS COMPLICATION RESULTED FROM FIREWOOD ABRASION WAS NOTED. OPEN AND DEBRIDEMENT OF RIGHT HAND. ANTIBIOTICS WERE GIVEN. DIAGNOSIS WAS INFECTIOUS FLEXOR TENOSYNOVITIS. NO DEVICE MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922651 ULTRAGUIDECTR CARPAL TUNNEL RELEASE SYSTEM LXH SONEX HEALTH 600112-001 00860002094700

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention