MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-11-06 for REVITIVE UNKNOWN manufactured by Actegy Ltd.
[126236437]
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.
Patient Sequence No: 1, Text Type: N, H10
[126236438]
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.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3010078417-2018-00010 |
MDR Report Key | 8041500 |
Report Source | CONSUMER |
Date Received | 2018-11-06 |
Date of Report | 2018-11-06 |
Date of Event | 2018-09-02 |
Date Mfgr Received | 2018-09-21 |
Date Added to Maude | 2018-11-06 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR LAWRENCE BROOKFIELD |
Manufacturer Street | REFLEX CAIN ROAD |
Manufacturer City | BRACKNELL, BERKSHIRE RG121HL |
Manufacturer Country | UK |
Manufacturer Postal | RG12 1HL |
Manufacturer G1 | MIRAE MEDI & TECH CO., LTD |
Manufacturer Street | 22 BAEKSEOKGONGDAN 5-GIL, SEOBUK-GU, |
Manufacturer City | CHEONAN-SI,, CHUNGCHEONGNAM-DO |
Manufacturer Country | KS |
Single Use | 3 |
Remedial Action | PM |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | REVITIVE |
Generic Name | CIRCULATION BOOSTER |
Product Code | NGX |
Date Received | 2018-11-06 |
Model Number | UNKNOWN |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ACTEGY LTD |
Manufacturer Address | REFLEX, CAIN ROAD BRACKNELL, BERKSHIRE |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Life Threatening | 2018-11-06 |