WATER PIK SWI615

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-09 for WATER PIK SWI615 manufactured by .

Event Text Entries

[2622458] My daughter and i purchased a water pik sinusense battery operated nasal wash to help us with a severe cold that we've been dealing with. On about the third day, i noticed a brownish liquid dripping out of the battery compartment and into the saline to be rinsed through our sinuses. I opened the battery compartment to find the batteries corroded. I thought for sure i must have done something wrong, so i cleaned the entire machine and installed fresh batteries. The second set of batteries corroded within 24 hours. Now i'm left wondering which of my/our symptoms are as a result of the chemicals from the batteries being inhaled/ingested, and how many are just normal cold. It only took a brief search online to find many others with the same complaint. Saline leaking into the battery compartment and chemicals leaking back out. (b)(6). This date is an estimate. 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	MW5024967
MDR Report Key	2532190
Date Received	2012-04-09
Date of Report	2012-03-25
Date of Event	2012-03-24
Date Added to Maude	2012-04-13
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	0
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	WATER PIK
Generic Name	NONE
Product Code	KAR
Date Received	2012-04-09
Model Number	SWI615
Device Sequence No	1
Device Event Key	0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-04-09