IONIC BREEZE AIR PURIFIER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-04-10 for IONIC BREEZE AIR PURIFIER * manufactured by Ionic Breeze.

Event Text Entries

[265198] Every time the reporter uses the ionic breeze air purifier they develop a very frightening pneumonia-like illness with low-grade fever, very congested lungs, headache, sinus infection, cough, pain in chest, etc. The fluid in lungs has a very strange taste also and the air in room smells odd when the reporter uses the product. This problem has happened every time they've used this product in the past year -last spring/summer and this spring-, but the reporter finally just realized that it was the product doing it in 4/2003. The reporter can turn the condition on and off by using or not using the product, although it takes a few days to develop in the first place and several days/weeks/or a month to get rid of once they stop using it.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1028126
MDR Report Key	453954
Date Received	2003-04-10
Date of Report	2003-04-10
Date of Event	2003-03-03
Date Added to Maude	2003-04-17
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	0
Report to FDA	0
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	IONIC BREEZE AIR PURIFIER
Generic Name	AIR FILTER
Product Code	FRF
Date Received	2003-04-10
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Operator	LAY USER/PATIENT
Device Availability	Y
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	442958
Manufacturer	IONIC BREEZE
Manufacturer Address	* * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2003-04-10