SS6- | Medtronic

Indications, Safety, and WarningsIndications SwiftSet™* topical skin adhesive is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. SwiftSet™* topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.Contraindictions

Do not use on any wounds with evidence of active microbial, bacterial, or fungal infections or gangrene.

Do not use on mucosal surfaces or across mucocutaneous junctions, or on skin which may be regularly exposed to body fluids.

Do not use on patients that have a hypersensitivity to cyanoacrylates or formaldehyde.

Do not apply internally, inject intravascularly, or ingest.

Do not use on decubitus ulcers, animal or human bite wounds, or stab wounds.

Warnings

SwiftSet™* topical skin adhesive is a fast-setting adhesive capable of adhering to most body tissues and many other materials, such as latex gloves and stainless steel. Inadvertent contact with any body tissue, surface and/or equipment that is not disposable or that cannot be readily cleaned with a solvent such as acetone should be avoided.

Polymerization of SwiftSet™* topical skin adhesive may be accelerated by water or fluids containing alcohol. SwiftSet™* topical skin adhesive should not be applied to wet wounds.

SwiftSet™* topical skin adhesive should not be applied to the eye. If contact with the eye occurs, flush the eye copiously with saline or water. If residual adhesive remains, apply topical ophthalmic ointment to help loosen the bond and contact an ophthalmologist.

When closing facial wounds near the eye using SwiftSet™* topical skin adhesive, adjust the patient’s position so that any flow of the adhesive is away from the eye. The eye should be closed and protected with gauze. Strategic placement of petroleum jelly near the eye can be effective at preventing inadvertent flow of the adhesive into the eye. Use of adhesives near the eye has inadvertently caused some patients’ eyelids to be sealed shut. In some of these cases, general anesthesia and surgical intervention has been needed to open the eyelid.

SwiftSet™* topical skin adhesive will not adhere to skin pre-coated with petroleum jelly. Therefore, avoid using petroleum jelly on any skin area where SwiftSet™* topical skin adhesive is intended to adhere.

SwiftSet™* topical skin adhesive is not absorbable and therefore should not be used below the skin as it may cause a foreign body reaction.

SwiftSet™* topical skin adhesive should not be used in areas with high or increased skin tension, such as knuckles, elbows, or knees, unless the joint will be immobilized during the skin healing period or the skin tension has been decreased by application of another would closure device (e.g., sutures or skin staples) prior to application of SwiftSet™* topical skin adhesive.

Wounds treated with SwiftSet™* topical skin adhesive should be monitored for signs of infection. Wounds with signs of infection such as erythema, edema, warmth, pain, and/or drainage should be evaluated and treated according to standard practice for infection.

SwiftSet™* topical skin adhesive should not be used on wound sites that will be subjected to repeated or prolonged moisture or friction.

SwiftSet™* topical skin adhesive should be used only on wounds that have easily apposed edges which have been thoroughly cleaned, debrided, and otherwise closed in accordance with standard surgical practice. Local anesthetic should be used when necessary to ensure adequate cleansing and debridement.

SwiftSet™* topical skin adhesive should always be applied sparingly, either as minute drops or as a thin film bridging the wound and the aligned wound edges. Avoid pressure on the applicator to prevent wound edge separation, which could cause the topical skin adhesive to be interposed between the wound edges. Application and/or migration (leak) of the topical skin adhesive below the surface of the skin and between the wound edges may impair the healing process by forming a barrier.

SwiftSet™* topical skin adhesive polymerizes through an exothermic reaction in which a small amount of heat is released. With the proper technique of applying SwiftSet™* topical skin adhesive sparingly in minute drops or a thin film onto a dry wound, heat is released slowly, and the sensation of heat or pain experienced by the patient is minimized. However, if SwiftSet™* topical skin adhesive is applied so that large droplets of liquid are allowed to remain unspread, the patient may experience a sensation of heat or discomfort.

SwiftSet™* topical skin adhesive is packaged for a single patient use. Discard remaining opened material after each wound closure procedure.

Do not re-sterilize SwiftSet™* topical skin adhesive or include it in a procedure pack/tray that is to be sterilized prior to use. Exposure of SwiftSet™* topical skin adhesive, after its final manufacture, to excessive heat (as in autoclaves or ethylene oxide sterilization) or radiation (such as gamma or electron beam), is known to increase viscosity and may render the product unusable.

Precautions

This product is meant for external dermal application only.

Safety and effectiveness of SwiftSet™* topical skin adhesive has not been evaluated for use on wounds of patients with uncontrolled diabetes mellitus, diseases, or conditions that are known to interfere with the wound healing process, or a personal or family history of keloid formation or hypertrophic scarring.

Safety and effectiveness has not been evaluated on wounds that have been treated with SwiftSet™* topical skin adhesive and then exposed for prolonged periods of time to direct sunlight or tanning lamps.

SwiftSet™* topical skin adhesive permeability by topical medications or other fluids is not known and has not been studied.

Liquid, ointment, or cream medications should not be applied to the wound after closure with SwiftSet™* topical skin adhesive, as these substances may weaken the polymerized film which may allow for wound dehiscence.

If unintended bonding of intact skin with SwiftSet™* topical skin adhesive should occur, removal may be accomplished by using either acetone or petroleum jelly. Typical cleansers such as soap and other agents such as water, saline, Betadine^®*, or chlorhexidine gluconate are not expected to loosen the bond. Peel, do not pull skin apart.

SwiftSet™* topical skin adhesive is a viscous liquid prior to polymerization. To prevent inadvertent flow of SwiftSet™* topical skin adhesive to unintended areas: The wound should be placed in a horizontal position, with SwiftSet™* topical skin adhesive applied from above. SwiftSet™* topical skin adhesive should be applied in minute drops or as a thin film rather than in a few large droplets. Do not attach precision tip after using broad tip as adhesive may get transferred to hand and applicator body.

Do not attach precision tip after using broad tip as adhesive may get transferred to hand and applicator body.

Adverse reactions Clinical use of cyanoacrylate-based topical skin adhesives has suggested that the following adverse events may occur: wound dehiscence; infection; acute inflammation including erythema, edema and drainage; bonding to unintended tissues such as the eye; thermal discomfort during polymerization; allergic reaction; foreign body reaction; and chronic non-healing of a wound.TM* Third-party brands are trademarks of their respective owners.®* Third-party brands are trademarks of their respective owners.

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