REVITIVE UNKNOWN

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number3010078417-2018-00010
MDR Report Key8041500
Report SourceCONSUMER
Date Received2018-11-06
Date of Report2018-11-06
Date of Event2018-09-02
Date Mfgr Received2018-09-21
Date Added to Maude2018-11-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR LAWRENCE BROOKFIELD
Manufacturer StreetREFLEX CAIN ROAD
Manufacturer CityBRACKNELL, BERKSHIRE RG121HL
Manufacturer CountryUK
Manufacturer PostalRG12 1HL
Manufacturer G1MIRAE MEDI & TECH CO., LTD
Manufacturer Street22 BAEKSEOKGONGDAN 5-GIL, SEOBUK-GU,
Manufacturer CityCHEONAN-SI,, CHUNGCHEONGNAM-DO
Manufacturer CountryKS
Single Use3
Remedial ActionPM
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREVITIVE
Generic NameCIRCULATION BOOSTER
Product CodeNGX
Date Received2018-11-06
Model NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerACTEGY LTD
Manufacturer AddressREFLEX, CAIN ROAD BRACKNELL, BERKSHIRE


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2018-11-06

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