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INSTRUCTIONS FOR USE
FLOSEAL 5mL
FLOSEAL 10mL
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FLOSEAL [Hemostatic
Matrix] Indications
FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Important Risk
Information for FLOSEAL
Do not use FLOSEAL in
patients with known allergies to materials of bovine origin.
Do not use FLOSEAL in
the closure of skin incisions because it may interfere with the healing of the
skin edges.
FLOSEAL must not be
injected into blood vessels, or allowed to enter blood vessels. Do not apply in
the absence of active bleeding. Extensive intravascular clotting and even death
may result.
FLOSEAL is made from
human plasma. It may carry a risk of transmitting infectious agents, e.g.,
viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
FLOSEAL is not intended
as a substitute for meticulous surgical technique and the proper application of
ligatures or other conventional procedures for hemostasis.
Excess FLOSEAL (material
not incorporated in the hemostatic clot) should always be removed by gentle
irrigation from the site of application.
The maximum swell volume
of approximately 20% is achieved within about 10 minutes.
FLOSEAL should not be
used in conjunction with methylmethacrylate or other acrylic adhesives. Do not
use FLOSEAL on bone surfaces where adhesives will be required to attach a
prosthetic device.
RX only: For safe and proper use of this device,
please refer to full device Instructions For Use.
