NexFoam®

Technical Information


Intended Use:

NexFoam® Topical Hemostat Sponge is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

Contraindications:

NexFoam Topical Hemostat Sponge should not be used on patients who have known allergies to potato starch. Contains Amylopectin (potato starch) and hydroxyethylcellulose.

Warnings:

• NexFoam Topical Hemostat Sponge is not intended as a substitute for appropriate standard
of care procedures and meticulous surgical techniques.
• The safety and efficacy of NexFoam Topical Hemostat Sponge in combination with other
hemostatic devices has not been clinically evaluated and is therefore not recommended.

Precautions:

• Carefully read the Instructions for use prior to application.
• Single Use Only.
• Sterility not guaranteed if package is damaged or opened. Discard damaged or open packages.
• Expiration Date: This device should not be used after the end of the year and month shown.
• To prevent product contamination prior to application, always follow aseptic techniques.

Instructions:

1. Peel open NexFoam pouch and remove sponge.
2. Blot excess blood from the wound with gauze.
3. Apply NexFoam sponge to cover wound.
4. Apply gauze over sponge and hold in place until hemostasis is achieved.
5. If hemostasis has not been achieved, repeat steps 2-4 or use an alternate method of hemostasis treatment.
6. NexFoam leaves the site of placement by natural elimination or it may be aspirated from the application site at the direction of the physician.
7. Discard any unused product after opening.

Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. For detailed information regarding indications for use, warnings and precautions, see Instructions for Use.

Content taken from 50005 Rev. E