IONIC BREEZE AIR FRESHNER FOR BATHROOMS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-01 for IONIC BREEZE AIR FRESHNER FOR BATHROOMS * manufactured by Sharper Image.

Event Text Entries

[350972] Reporter purchased an ionic breeze as advertised on tv. A smaller free bathroom ionic device promising fresh air was included. The bathroom model had a buzzing sound and produced a significant quantity of ozone. Ozone is a proven risk factor for inducing lung cancer. Reporter returned the items and received a prompt refund, however reporter can not help but be concerned when they see the adds on tv for this product knowing that the fresh air that is advertised from this product is in at least some cases if not all very dangerous to the consumer. Reporter was treated with ozone as a teenager, before the dangers were clarified. Reporter did some internet research on ozone before returning the product and the results were clearly suggesting a strong health risk. Ozone does clean the air and kill bacteria but one is ill advised to put it in lungs in the name of clean air. Reporter sincerely hopes this is an isolated case, but because these machines are ionizers, reporter suspects that they all have at least a continuous low output of ozone which may outweigh the value of removing micro particles from the air.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1031024
• MDR Report Key: 511253
• Date Received: 2004-02-01
• Date of Report: 2004-02-01
• Date of Event: 2003-05-15
• Date Added to Maude: 2004-02-17
• 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: 3
• 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 FRESHNER FOR BATHROOMS
• Generic Name: IONIC AIR FRESHNER
• Product Code: FRA
• Date Received: 2004-02-01
• Returned To Mfg: 2003-05-15
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 500220
• Manufacturer: SHARPER IMAGE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-02-01