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Absorbable Hemostat

(Collagen Sponge Hemostat)



PAHACEL® Absorbable Hemostat is an absorbable Collagen sponge for hemostatic use on bleeding surfaces. PAHACEL® Collagen Sponge Hemostat is beige in appearance and a gamma sterilized sponge.

Absorbable Hemostat (Collagen Sponge Hemostat) having properties of:

Indications

PAHACEL Collagen Sponge Hemostat is used in surgical procedures to assist in the ceasing and control of capillary, venous and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective.

Contraindications

Do not use PAHACEL® Collagen Sponge Hemostat in closure of skin incisions because it may interfere with the healing of skin edges. This interference is due to mechanical interposition of Collagen and is not secondary to intrinsic interference with wound healing. Do not use PAHACEL® Collagen Sponge Hemostat in intravascular compartments because of the risk of embolization. Do not use PAHACEL® Collagen Sponge Hemostat in patients with known allergies to gelatin.

Warnings

PAHACEL® Gelatin Sponge Hemostat is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.

PAHACEL® Collagen Sponge Hemostat should not be used in the presence of infection. PAHACEL® Collagen Sponge Hemostat should be used with caution in contaminated areas of the body. If signs of infection or abscess develop where PAHACEL® Collagen Sponge Hemostat has been positioned, reoperation may be necessary in order to remove the infected material and allow drainage.

PAHACEL® Collagen Sponge Hemostat should not be used in instances of pumping arterial hemorrhage. It should not be used where blood or other fluids have pooled or in cases where the point of hemorrhage is submerged. PAHACEL® Collagen Sponge Hemostat will not act as a tampon or plug in a bleeding site, nor will it close off an area of blood collecting behind a tampon.

PAHACEL® Collagen Sponge Hemostat should be removed if possible once hemostasis has been achieved because of the possibility of dislodgment of the device or compression of other nearby anatomic structures.

PAHACEL® Collagen Sponge Hemostat should be removed from the site of application when used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm. Care should be exercised to avoid overpacking. PAHACEL® Collagen Sponge Hemostat may swell creating the potential for nerve damage.

The safety and effectiveness of PAHACEL® Collagen Sponge Hemostat for use in ophthalmic and urological procedures has not been established.

PAHACEL® Collagen Sponge Hemostat should not be used for controlling post-partum intrauterine bleeding or menorrhagia.

The safety and effectiveness of PAHACEL® Collagen Sponge Hemostat has not been established in children and pregnant women.

Precautions

PAHACEL® Collagen Sponge Hemostat is supplied as a sterile product and cannot be resterilized.

While packing a cavity for hemostasis is sometimes surgically indicated, PAHACEL® Collagen Sponge Hemostat should not be used in this manner unless excess product that is not needed to maintain hemostasis is removed.

Only the required amount of PAHACEL® Collagen Sponge Hemostat needed to achieve hemostasis should be used. Once hemostasis is achieved, any excess PAHACEL® Collagen Sponge Hemostat should be carefully removed.

PAHACEL® Collagen Sponge Hemostat should not be used in conjunction with autologous blood salvage circuits.

PAHACEL® Collagen Sponge Hemostat should not be used in conjunction with methylmethacrylate adhesives.

PAHACEL® Collagen Sponge Hemostat should not be used for the primary treatment of coagulation disorders.

Although, the safety and effectiveness of the combined use of PAHACEL® Collagen Sponge Hemostat with other agents such as topical thrombin, antibiotic solution or antibiotic powder has not been evaluated in controlled clinical trials, if in the physician's judgment, concurrent use of topical thrombin or other agents is medically advisable, the product literature for that agent should be consulted for complete prescribing information.

Classification

PAHACEL® Collagen Sponge Hemostat is classified as Class III according to Medical Device Directives.

Sterility

Pahacel® Absorbable Hemostat (Collagen Sponge Hemostat) is sterilized by Gamma irradiation technique.

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