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 NumberMW5024047
MDR Report Key2434529
Date Received2012-01-24
Date of Report2011-10-08
Date of Event2011-10-08
Date Added to Maude2012-02-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameWATERPIK SINUSENSE
Generic NameSINUS IRRIGATOR
Product CodeKMA
Date Received2012-01-24
Model NumberSINUSENSE SWI 615
OperatorLAY USER/PATIENT
Device Sequence No1
Device Event Key0
ManufacturerWATER PIK, INC


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-01-24

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