MAUDE Adverse Event Report: ACTEGY LTD CBV3; CIRCULATION BOOSTER

Model Number CBV3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 08/21/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturer's analysis: the device is not contraindicated for use in the presence of varicosities.The instructions for use (ifu) describes an adequate setting as when the individual can "feel the mild electrical impulses in your feet and the muscles in the calf visibly pulsing or twitching but at a level that is not uncomfortable".The device intensity range is 0-99 (0 being the lowest, and 99 being the highest intensity setting).The individual has stated that they used the device at an intensity of "9-12".We believe it is most likely that the user in this case, (b)(6), has not used the device as described in the ifu.The intensity has not been applied at a sufficiently high enough intensity to create the required muscle contraction.We expect that the device would have had little effect at this level of intensity, if at all.Therefore we believe the most likely cause of varicose veins in this (b)(6) lady, is the natural progression of her underlying medical condition.Case closed as patient underlying medical condition is not device related.

Event Description

Please note: following an fda inspection at actegy ltd between march 5-8, 2018 by mr.(b)(4) it was identified this incident should have been reported to fda.Therefore, the following incident is being reported retrospectively: following the purchase of the new device and use for 6 months (b)(6) reported that she has suffered from varicosities on both her legs and that her veins have gradually increased in size since the first and subsequent use of the device ((b)(6) 2017).According to (b)(6) the device was purchased to relieve a "tingling sensation" in her legs and was being used for 30 minutes every day on intensity levels between 9 and 12.On (b)(6) 2017 (b)(6) doctor provided a letter to actegy ltd advising that her patients varicose vein condition had occurred following the use of the device which had not existed prior to this.The doctor also advised that these symptoms would likely require specialist intervention (laser or local sclerosis) following the aesthetic concerns raised by her patient.

• Brand Name: CBV3
• Type of Device: CIRCULATION BOOSTER
• Manufacturer (Section D): ACTEGY LTD; reflex; cain road; bracknell, berkshire RG12 1HL; UK RG12 1HL
• Manufacturer (Section G): MIRA MEDI & TECH CO., LTD; 22 baeksuk-dong 5-gil; seobuk-gu; cheonan city, ; KS
• Manufacturer Contact: lawrence brookfield ; reflex; cain road; bracknell, berkshire RG12 -1HL ; UK RG12 1HL
• MDR Report Key: 7553406
• MDR Text Key: 109578043
• Report Number: 3010078417-2018-00005
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CBV3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 YR
• Event Location: Home
• Date Manufacturer Received: 08/21/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 82 YR