MAUDE Adverse Event Report: ACTEGY LTD REVITIVE; CIRCULATION BOOSTER

Model Number UNKNOWN

Device Problem No Apparent Adverse Event (3189)

Patient Problem Thrombosis (2100)

Event Date 09/02/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Event Description

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.

Manufacturer Narrative

This report is being submitted retrospectively per fda request.

• Brand Name: REVITIVE
• Type of Device: CIRCULATION BOOSTER
• Manufacturer (Section D): ACTEGY LTD; reflex, cain road; cain road; bracknell, berkshire RG12 1HL; UK RG12 1HL
• Manufacturer (Section G): MIRAE MEDI & TECH CO., LTD; 22 baekseokgongdan 5-gil,; seobuk-gu,; cheonan-si,, chungcheongnam-do ; KS
• Manufacturer Contact: lawrence brookfield ; 22 baekseokgongdan 5-gil,; seobuk-gu,; cheonan-si,, chungcheongnam-do RG12 -1HL ; KS RG12 1HL
• MDR Report Key: 8041500
• MDR Text Key: 126236437
• Report Number: 3010078417-2018-00010
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: 09/21/2018
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White