BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAGUIDE TFR

    MDR report key: 16950023 · Received May 17, 2023

    Report

    Report Number
    3013479847-2023-00001
    Event Type
    Injury
    Date Received
    May 17, 2023
    Date of Event
    January 30, 2023
    Report Date
    May 17, 2023
    Manufacturer
    SONEX HEALTH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. TENOSYNOVITIS IS A POTENTIAL ROOT CAUSE OF THE PROLONGED RECOVERY, WITH UNINTENTIONAL INJURY TO THE A2 PULLEY ALSO A POTENTIAL ROOT CAUSE, ALTHOUGH THE PATIENT'S SYMPTOMS ARE NOT TYPICAL OF AN A2 INJURY. DELAYED HEALING AND INJURY TO THE A2 PULLEY ARE LISTED N THE INSTRUCTIONS FOR USE AS A POTENTIAL COMPLICATION OF THE PROCEDURE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PROCEDURE UTILIZING ULTRAGUIDETFR ON (B)(6) 2023. THE PHYSICIAN REPORTED THE PROCEDURE WAS UNEVENTFUL, THE DEVICE FUNCTIONED NORMALLY, AND THERE WERE NO TECHNICAL CHALLENGES. THE PATIENT EXPERIENCED PROLONGED RECOVERY AND ONGOING PAIN, STIFFNESS AND SWELLING 3 MONTHS POST-PROCEDURE, WITH SYMPTOMS PERSISTING AS OF (B)(6) 2023. THE PATIENT REPORTED THAT SHE NEVER IMPROVED SIGNIFICANTLY POST-PROCEDURE. AN INITIAL MRI REPORT INDICATES THERE IS FLUID IN THE FLEXOR TENDON SHEATH, A RELEASED A1 PULLEY, AND TRANSECTION OF THE A2 PULLEY. HOWEVER, A PRECISE DIAGNOSIS REMAINS UNCERTAIN AS THE PATIENT'S SYMPTOMS ARE NOT TYPICAL OF TRIGGER FINGER RELEASE PROCEDURES OR A2 PULLEY INSUFFICIENCY. A COURSE OF ORAL STEROIDS HAD TEMPORARILY IMPROVED SYMPTOMS. THE PATIENT RECEIVED A RECENT CORTISONE INJECTION, BUT IT IS UNKNOWN IF THIS INJECTION HAS HELPED THE PATIENT. THE PATIENT CONTINUES TO UNDERGO TREATMENT INCLUDING PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706276 ULTRAGUIDE TFR Orthopedic manual surgical instrument LXH SONEX HEALTH USG2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other