BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITIVE

    MDR report key: 8041500 · Received November 6, 2018

    Report

    Report Number
    3010078417-2018-00010
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    September 2, 2018
    Report Date
    November 7, 2018
    Manufacturer
    ACTEGY LTD
    Product Code
    NGX
    PMA / PMN Number
    K152480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST.

    Description of Event or Problem · 0

    ON 21ST SEPTEMBER 2018, ACTEGY LTD WERE MADE AWARE OF AN INCIDENT INVOLVING A REVITIVE CIRCULATION BOOSTER. THE CUSTOMER (MR. (B)(6) WHO PURCHASED THE DEVICE BECAUSE ALTHOUGH HEALTH WAS GOOD HIS LEGS WERE HURTING AND JUMPING ALL THE TIME. ON (B)(6) 2018, THE CUSTOMER REPORTS THAT WITHIN 2 HOURS OF USING THE DEVICE HIS RIGHT LEG SWELLED UP TO APPROXIMATELY ONE AND HALF TIME THE NORMAL SIZE AS THE RESULT OF A DEEP VEIN THROMBOSIS (DVT). THREE DAYS LATER A DOPPLER ULTRASOUND WAS CONDUCTED AND NO DVT OR BLOOD CLOTS COULD BE IDENTIFIED. THE DOCTOR PRESCRIBED THE CUSTOMER WITH BLOOD THINNING DRUGS AND EXERCISES.

    Additional Manufacturer Narrative · 1

    ALL CIRCULATION BOOSTER INSTRUCTIONS FOR USE STATES THE FOLLOWING: DO NOT USE IF (CONTRAINDICATIONS): LONG PERIODS OF INACTIVITY CAN PUT YOU AT GREATER RISK OF DEVELOPING DEEP VEIN THROMBOSIS (DVT). DVT IS A BLOOD CLOT AND USUALLY OCCURS IN A DEEP LEG VEIN. IF PART OF THE DVT BREAKS OFF IT MAY BE POTENTIALLY LIFE THREATENING COMPLICATIONS SUCH AS A PULMONARY EMBOLISM. IF YOU HAVE BEEN INACTIVE FOR PROLONGED PERIODS AND SUSPECT YOU HAVE A DVT, CONSULT YOUR DOCTOR IMMEDIATELY. TO PREVENT DISLODGING THE CLOT DO NOT USE THE REVITIVE. ON SOME CASES OF DVT THERE MAY BE NO SYMPTOMS. HOWEVER, IT IS IMPORTANT TO BE AWARE OF THE SYMPTOMS THAT MAY INCLUDE: PAIN, SWELLING AND TENDERNESS IN ONE OF YOUR LEGS (USUALLY YOUR CALF), A HEAVY ACHE IN THE AFFECTED AREA, WARM SKIN IN THE AREA OF THE CLOT, REDNESS OF YOUR SKIN, PARTICULARLY AT THE BACK OF YOUR LEG BELOW THE KNEE. CONSULT YOUR DOCTOR AS SOON AS POSSIBLE IF YOU SHOW ANY SIGNS OF THE ABOVE SYMPTOMS.

    Description of Event or Problem · 1

    ON (B)(4) 2018 ACTEGY LTD WERE MADE AWARE OF AN INCIDENT INVOLVING A REVITIVE CIRCULATION BOOSTER. THE CUSTOMER (MR (B)(6)) WHO PURCHASED THE DEVICE BECAUSE ALTHOUGH HEALTH WAS GOOD HIS LEGS WERE HURTING AND JUMPING ALL THE TIME. ON (B)(6) 2018 THE CUSTOMER REPORTS THAT WITHIN 2 HOURS OF USING THE DEVICE HIS RIGHT LEG SWELLED UP TO APPROXIMATELY ONE AND HALF TIME THE NORMAL SIZE AS THE RESULT OF A DEEP VEIN THROMBOSIS (DVT). THREE DAYS LATER A DOPPLER ULTRASOUND WAS CONDUCTED AND NO DVT OR BLOOD CLOTS COULD BE IDENTIFIED. THE DOCTOR PRESCRIBED THE CUSTOMER WITH BLOOD THINNING DRUGS AND EXERCISES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882711 REVITIVE CIRCULATION BOOSTER NGX ACTEGY LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening