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U.S. Department of Health and Human Services

Safety

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Absorbable Hemostatic Agents

Audience: Neuropsychiatric healthcare professionals

The FDA Center for Devices and Radiological Health (CDRH) issued a Public Health Notification concerning a serious adverse event that can occur with the use of an absorbable hemostatic agent, a device used to promote coagulation and stop internal bleeding during surgical procedures. Since 1996, FDA has received reports of over 110 adverse events related to absorbable hemostatic agents. Eleven of the events resulted in paralysis or other neural deficits. These events continue to occur despite specific advice and warnings in the device labeling. CDRH provided recommendations to minimize the risk of adverse events in patients receiving an absorbable hemostatic agent during a surgical procedure.

[April 02, 2004 Public Health Notification - FDA]