D
Patient 1
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.