[19674072]
Used veinwave device on nose and face. Pt presented back to office 3 days later with innumerable punctate red marks and lines in treated areas. Unable to get response from us distributor of possible cause and/or recommended therapy. After multiple threatening messages via phone and email, get a response from a company, fcare systems usa who claimed to be mfr of device. Expressed my concern about power output from device and possible disfiguration/scarring. Was told that if pt was only treated once, marks would likely resolve in approx 6 weeks but multiple treatments would result in permanent scarring. Also told that the control board for device could be bad and, therefore, they would need to evaluate device itself. Sent device to fcare who evaluated device and did find faulty control board resulting in maximum output to needle tip resulting in the clinical findings i described. Power control board upgraded from v5 to v6 (according to f/u correspondence from fcare). Expressed my concern about using device on another pt without some reassurance that system would not silently fail again (won't know until pt's returned disfigured). To that end, i asked for some sort of meter or test device to insure power output at needle tip was congruent with stated power on device. Was told that the equipment was too expensive to be used in that manner and therefore, was cost prohibitive. Asked if there was an alternative methodology. Was told to put needle on my own finger and activate. If the feeling was really painful, probably too much power at tip. To date, still can't get a hold of any representative from veincare to report issue or devise a reasonable solution. Have called all the numbers on the brochure, sent correspondence via email and web page contacts as well as registered letter asking for assistance (which was subsequently returned as "address unknown"). Have used this device for almost 7 months prior to this incident with excellent results. Unwilling to use it again, however, without some sort of reassurance from the company that this can't happen again (would rather device fail completely if control board goes bad then disfigure patients). Date of use: (b)(6) 2011. Reason for use: thread vein base of nose and cheeks.
Patient Sequence No: 1, Text Type: D, B5