Hemostatic agent leads to 110 adverse events
Since 1996, the Food and Drug Administration (FDA) has received reports of more than 110 adverse events related to absorbable hemostatic agents, including 11 that resulted in paralysis or other neural deficits.
The device is used to promote coagulation and stop internal bleeding during surgical procedures.
Review the device label, especially the contraindications, warnings, and precautions, suggests the FDA’s Center for Devices and Radiological Health (CDRH). If you use an absorbable hemostatic agent on or near bony or neural spaces:
- Use the minimum amount necessary to achieve hemostasis.
- Remove as much of the agent as possible after hemostasis is achieved.
This will reduce the likelihood of neural and other soft tissue damage from swelling of the absorbable hemostatic agent, and/or migration and swelling of fragments of the agent, according to the CDRH. For more information, see the notice at www.fda.gov/cdrh/safety/040204-hemostatics.html.
CDRH encourages providers to report adverse events related to absorbable hemostatic agents, even if they don’t meet the requirements for mandatory reporting.
You can report these directly to the device manufacturer. You also can report to MedWatch, the FDA’s voluntary reporting program.
You may submit reports to MedWatch by phone at (800) FDA-1088; by fax at (800) FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or on-line at www.fda.gov.