WATERPIK SINUSENSE SINUSENSE SWI 615

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-24 for WATERPIK SINUSENSE SINUSENSE SWI 615 manufactured by Water Pik, Inc.

Event Text Entries

[2472302] I purchased a waterpik sinusense automatic (electric/battery powered) sinus cleaner from (b)(6) about a month ago. I have serious sinus issues and for the first week, the sinusense was helping greatly. Then, my sinus problems started getting worse than they were before i started using the product. Come to find out, the battery compartment was leaking battery acid into the sterile saline compartment. Basically, i was flushing my sinuses with extremely harmful battery acid. I am now worried that i did permanent damage to my sinuses. I followed every direction to the t, and i in no way misused this product. I did a search for the product online and almost everyone is having the same problem with this device. Waterpik doesn't seem to think it's a big deal, and only offers to replace the product when people complain. This is serious. Many unsuspecting people with this product could be flushing their sinuses with battery acid as we speak. You can read some of the reviews for the product here: (b)(4). Retailer: (b)(6). The product was not damaged before the incident. The product was not modified before the incident.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5024047
• MDR Report Key: 2434529
• Date Received: 2012-01-24
• Date of Report: 2011-10-08
• Date of Event: 2011-10-08
• Date Added to Maude: 2012-02-01
• 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: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WATERPIK SINUSENSE
• Generic Name: SINUS IRRIGATOR
• Product Code: KMA
• Date Received: 2012-01-24
• Model Number: SINUSENSE SWI 615
• Operator: LAY USER/PATIENT
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: WATER PIK, INC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2012-01-24