[578386]
This is a copy of the letter i sent to the device mfr: since 06/05, i have owned three hydro-pulse sinus irrigation systems. The first one which i purchased upon the recommendation of dr of the school of medicine began leaking within six months of use, and shorted-out shortly thereafter. You replaced that one, with the unit that is the subject of this letter. I have a third device which is not used often. The replacement device was put into service in 06/06. It began leaking, exactly as the first one did, in 11/06. Last week, after returning from a week of travel, the device would not turn on. I left it plugged in, and within a hour smelled the distinctive order of burning electrical insulation. I discovered that the unit was hot to touch, and beginning to smoke. I unplugged it and removed it from my home. I estimate that this unit was used less than 300 times. At this point, i will not use the hydro-pulse device as i deem it an unacceptable shock and fire hazard. I am writing to inform you of this serious problem. As noted i have copied dr, as he should be apprised of this, also. Further, while i believe this device is regulated by the u. S. Consumer product safety commision, it could actually be under the jurisdiction of the u. S. Food and drug administration, as a medical device. Thus, i have copied this letter to both of those agencies. I look forward to your prompt attention to this and hope the problem is resolved before anyone is injured.
Patient Sequence No: 1, Text Type: D, B5