Adverse Reactions; How Supplied - Bard Avitene Ultrafoam Instructions For Use Manual

• A ™ U
VITENE LTRAFOAM
• Not for injection, intraocular or intravascular use.
PRECAUTIONS
• A ™ U
VITENE LTRAFOAM
on infected surfaces.
• As with other hemostatic agents, it is not recommended for use in persons with known sensitivity
to material of bovine origin.
• Any excess A
VITENE
a (recurring) mass or a (space occupying) lesion or it may lead to a foreign body reaction that may
present with or without clinical signs and symptoms as a recurring mass or lesion or postoperative
abscess formation upon imaging. Imaging may initially not be capable of distinguishing the
difference. Removal of excess material, ideally performed upon conclusion of the initial procedure,
typically resolves all signs and symptoms.
• Microfi brillar Collagen Hemostat (MCH) contains a low, but detectable, level of intercalated bovine
serum protein which reacts immunologically as does beef serum albumin. Increases in anti-BSA
titer have been observed following treatment with MCH. About two-thirds of individuals exhibit
antibody titers because of ingestion of food products of bovine origin. Intradermal skin tests have
occasionally shown a weak positive reaction to BSA or MCH but these have not been correlated
with IgG titers to BSA. Tests have failed to demonstrate clinically signifi cant elicitation of antibodies
of the IgG class against BSA following MCH therapy.
• When placed into cavities or closed spaces, care should be exercised to avoid overpacking
A ™ U
VITENE LTRAFOAM
• The safety of this product has not been established in children or in pregnant women; therefore,
A ™ U
VITENE LTRAFOAM
risks clearly warrant its use.

ADVERSE REACTIONS

• The most serious adverse reactions reported, which may be related to the use of other collagen
products, are potentiation of infection including abscess formation, hematoma, wound dehiscence
and mediastinitis.
• Other reported adverse reactions possibly related are adhesion formation, allergic reaction,
foreign body reaction and subgaleal seroma (report of a single case), and increased incidence of
alveolalgia when used for packing of dental extraction sockets.

HOW SUPPLIED

A ™ U ™ sponge is supplied sterile and non-pyrogenic. The sterility of this product is
VITENE LTRAFOAM
guaranteed unless the foil pouch is opened or damaged.
Reorder Number
1050020
1050030
1050040
1050050
Avitene, Bard, Davol and Ultrafoam are trademarks and/or registered trademarks of C. R. Bard, Inc. or
an affi liate.
Copyright © 1998, 2004, 2009 - 2011 C. R. Bard, Inc. All Rights Reserved.
Manufacturer:
Davol Inc.
Subsidiary of C. R. Bard, Inc.
100 Crossings Boulevard
Warwick, RI 02886 USA
1-401-825-8300 • 1-800-556-6275
www.davol.com
™ sponge is not intended to treat systemic coagulation disorders.
™ sponge, like other collagen hemostats, should not be left in infected sites or
™ U ™ not removed at the time of surgery may either present itself as
LTRAFOAM
™ sponge as it may press against neighboring structures.
™ sponge should only be used after an evaluation of the relative benefi ts and
Size
12.5 sq. cm 2cm x 6.25cm x 7mm
50 sq. cm 8cm x 6.25cm x 1cm
100 sq. cm 8cm x 12.5cm x 1cm
100 sq. cm 8cm x 12.5cm x 3mm
THIN
Bard Limited
Crawley, UK
RH11 9BP
Medical Services & Support
Clinical Information Line
1-800-562-0027
Description
3/4" x 2 1/2" x 1/4"
3 1/8" x 2 1/2" x 3/8"
3 1/8" x 5" x 3/8"
3 1/8" x 5" x 1/8"
Units/Case
12
6
6
6
To Reorder Call:
1-800-556-6275