BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENEX HEALTH TX 2

    MDR report key: 6916053 · Received October 5, 2017

    Report

    Report Number
    MW5072607
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    December 30, 2016
    Report Date
    October 3, 2017
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WHO PRESENTS TODAY FOR A FOLLOW UP VISIT. HE IS 8 MONTHS OUT FROM A TENEX 2 PROCEDURE ON HIS RIGHT PROXIMAL HAMSTRING ON (B)(6) 2016. HE STATES THE SYMPTOMS ARE BETTER SINCE THE PREVIOUS OFFICE VISIT. THE PATIENT COMPLAINS OF THE FEELING OF A FOREIGN BODY IN HIS OUTER THIGH. HE HAS RETURNED TO RUNNING, AND HAS NO COMPLAINTS DURING ACTIVITY. HOWEVER, THE FOREIGN BODY HAS MADE THAT AREA OF HIS THIGH TENDER AND SENSITIVE. USING STERILE TECHNIQUE, THE SKIN WAS PREPPED WITH ALCOHOL SWABS AND 2 ML OF LIDOCAINE WITHOUT EPINEPHRINE WAS INJECTED. SUBSEQUENTLY A 3 MM INCISION WAS MADE AT THE ANTERIOR END THE FOREIGN BODY AND USING BLUNT DISSECTION THE TIP OF THE METAL SHEATH WAS IDENTIFIED. A 5 CM METALLIC SHEATH WAS REMOVED IN ITS ENTIRETY. THE INSTRUMENT WAS INSPECTED FOR ANY DEFECTS AND ULTRASOUND WAS PERFORMED AFTER REMOVAL TO EVALUATE FOR ANY RETAINED FOREIGN MATTER. IN REVIEW OF THE RETAINED ITEM, APPEARS IT IS THE NEEDLE OF THE TENEX 2. IT IS ALSO NOTED A PRODUCT BULLETIN WAS ISSUED ON (B)(6) 2017. "USE OF AN OUT-OF-PLANE MOTION (SWEEPING OR SIDE-SIDE) INSTEAD OF THE PRESCRIBED AXIAL MOTION (LONGITUDINAL) HAS RESULTED IN DAMAGE OR SEPARATION OF THE HYPODERMIC NEEDLE AND/OR IRRIGATION SHEATH ATTACHED TO THE MICROTIP." PROVIDER DENIES USE OF A SWEEPING OR SIDE-SIDE MOTION IN THIS CASE WHICH RESULTED IN THE NEEDLE SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695410 TENEX HEALTH TX 2 TENEX HEALTH TX 2 LFL TENEX HEALTH, INC. 554-1001-001 28116-01

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention