MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-05-30 for CBV3 manufactured by Actegy Ltd.
[109578043]
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.
Patient Sequence No: 1, Text Type: N, H10
[109578044]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010078417-2018-00005 |
| MDR Report Key | 7553406 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-05-30 |
| Date of Report | 2018-05-30 |
| Date of Event | 2017-08-21 |
| Date Mfgr Received | 2017-08-21 |
| Date Added to Maude | 2018-05-30 |
| 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 | MIRA MEDI & TECH CO., LTD |
| Manufacturer Street | 22 BAEKSUK-DONG 5-GIL SEOBUK-GU |
| Manufacturer City | CHEONAN CITY, |
| Manufacturer Country | KS |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CBV3 |
| Generic Name | CIRCULATION BOOSTER |
| Product Code | NUH |
| Date Received | 2018-05-30 |
| Model Number | CBV3 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACTEGY LTD |
| Manufacturer Address | REFLEX CAIN ROAD BRACKNELL, BERKSHIRE RG121HL UK RG12 1HL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-30 |