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 Nerve Damage (1979)

Event Date 03/16/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturers device analysis results: the device was tested on the 28-apr-2015 and was found to be working in specification.Medical opinion was sought from dr (b)(6) who along with actegy have made several attempts to contact dr f.Goh for the patient medical history but has had no response to date.Based on the limited information available dr c.Baxter was unable to fully assess the complaint due to the lack of medical information, preliminary assessment is as follows: a (b)(6) male patient with a history of (b)(6) (bmi=33.75) and hernia describes bilateral foot pain after 18 months use of the revitive circulation booster (cbv3) device.The patient has attended his primary care physician, where hyperuricaemia has been excluded.The presence of varicose veins in the lower legs was noted by the patient's physician.There is no evidence of peripheral arterial disease in the legs.The patient was prescribed analgesia (which he has discontinued due to unspecified adverse reactions) and a specialist referral made, although the nature of this referral is unclear (e.G.The referral may have been to a neurologist for further investigation and nerve conduction studies, or to a surgeon for treatment of varicose veins).There has been no written or other confirmation of causality by the physician concerned.Before this case can be fully assessed, further information and medical opinion is required from the treating physician, especially with regard to the nature of the patient's symptoms, co-morbidities, co-medications and other possible explanations for the symptoms described above as peripheral neuropathy is a relatively common condition and has many possible aetiologies in (b)(6) males.There is insufficient information to make a formal causality assessment.The complaint is being closed due to the lack of information as it cannot be fully assessed and no firm conclusion be reached.Remedial action/corrective action/preventative action: despite multiple requests for information by telephone, email and letter further information from the patient and treating physician has not been forthcoming.Owing to the lack of definitive medical information from the treating physician it is not possible to continue investigation into this incident.Information to date suggests that the incident is a result of underlying patient condition rather than device related.The device has been confirmed to be working within intended specifications.No preventative or corrective action is required, however actegy reserve the right to re-investigate the complaint if new information becomes available.Events of this nature will continue to be monitored through post- market surveillance.Corrective action taken relevant to the care of the patient: patient has discontinued use of the device upon advice of the doctor.Patient history (co-morbidities & medication): prior history of hernia which limits mobility, otherwise no prior medical history.Patient outcome: patient in receipt of prescription for analgesics - since discontinued due to side effects.Referral to specialist (b)(6) 2015 - awaiting outcome.

Event Description

Please note: following an fda inspection at actegy ltd between march 5-8, 2018 by mr (b)(6) it was identified this incident should have been reported to fda.Therefore, the following incident is being reported retrospectively: the patient notified actegy on the (b)(6) 2015 that he had been using his revitive device daily for 30 minutes on intensity 25 for approximately 18 months until he started to feel pain in his feet, after which he used the device on the same settings once a week for a further period of 3 months.The user went to his doctor (b)(6) 2015 as he was concerned about the pain and was told that he had suffered "irreversible damage to the nerves in his feet", he was prescribed pain killers - tramadol and voltaren and told not to use the device.The patient has since discontinued pain killers due to side effects.Referral letter from patient doctor dated (b)(6) 2015 states patient presented experiencing pain and soreness in feet and calves, uric acid levels normal, some varicose veins noted on feet extending to mid calves with no warmth or swelling - pulses intact and peripheral circulation normal.

• 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): MIRAE MEDI & TECH CO., LTD; 22 baekseokgongdan 5-gil; seobuk-gu, cheonan city; chungnan, ; KS
• Manufacturer Contact: lawrence brookfield ; reflex; cain road; bracknell,, berkshire RG12 -1HL ; UK RG12 1HL
• MDR Report Key: 7552345
• MDR Text Key: 109491144
• Report Number: 3010078417-2018-00003
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2012
• 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: 66 YR
• Patient Weight: 90