HYDRO-PULSE SINUS IRRIGATION SYSTEM CURRENT MODEL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-01 for HYDRO-PULSE SINUS IRRIGATION SYSTEM CURRENT MODEL * manufactured by Hydro-med, Inc.

Event Text Entries

[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

MAUDE Entry Details

• Report Number: MW1041838
• MDR Report Key: 813346
• Date Received: 2007-02-01
• Date of Report: 2007-02-01
• Date of Event: 2007-01-06
• Date Added to Maude: 2007-02-08
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HYDRO-PULSE SINUS IRRIGATION SYSTEM
• Generic Name: NA
• Product Code: KAR
• Date Received: 2007-02-01
• Model Number: CURRENT MODEL
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 800833
• Manufacturer: HYDRO-MED, INC
• Manufacturer Address: 4419 VAN NUYS BLVD SHERMAN OAKS CA 91403 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2007-02-01