FDA MedWatch - OxySure Portable Emergency Oxygen System, Model 615 by OxySure Therapeutics, Inc: FDA Safety Communication - Do Not Use

OxySure Portable Emergency Oxygen System, Model 615 by OxySure Therapeutics, Inc: FDA Safety Communication - Do Not Use

AUDIENCE: Consumer, Health Care Providers

ISSUE: The FDA is recommending consumers, businesses, schools, and health care providers stop using OxySure Portable Emergency Oxygen System, Model 615 because of several device malfunctions, including ineffective oxygen delivery, and chemical reactions in the canisters that could cause them to explode.

Due to adverse event reports to the FDA and the company’s failure to address the device’s safety issues noted during inspections and in the FDA’s warning letter, the FDA is concerned that patients and other users of OxySure Portable Emergency Oxygen System, Model 615 are at risk for serious adverse health consequences, such as burns and death.

The FDA will continue to work with OxySure Therapeutics, Inc. to bring these devices into regulatory compliance and will keep the public informed if significant new information becomes available.

BACKGROUND: OxySure Portable Emergency Oxygen System is intended to produce oxygen for emergency use.

Since June 2013, OxySure Therapeutics, Inc. has distributed at least 1,000 units of the OxySure Portable Emergency Oxygen System, Model 615 nationwide. These devices may be purchased without a prescription and can be used in businesses, schools, and other public places (e.g.., gyms, shopping malls, and airports). See the FDA Safety Communication for additional information.

RECOMMENDATION: The FDA recommends customers stop using the OxySure Portable Emergency Oxygen System, Model 615 and immediately transition to an alternative FDA-cleared emergency oxygen device.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm492970.htm

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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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