Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism
MedSun: Newsletter #51, August 2010

FDA MedWatch Safety Alert

FDA has received reports of air or gas embolism occurring during or immediately after application of hemostatic drug or biological products using air- or gas-pressurized sprayers. These adverse events appear to be related to use of spray devices inconsistent with the approved product labeling and instructions for use. In some reports the device was used at higher than recommended pressure or at a distance too close to the surface of the bleeding site.

Additional Information:

FDA MedWatch Safety Alert. Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism. July 9, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218530.htm


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