DISCLAIMER
High viscosity DERMABOND® Adhesive is a fast setting adhesive capable of adhering to most body tissue and many other materials, such as latex gloves and stainless steel. Inadvertent contact with any body tissue, and any surfaces or equipment that are not disposable or that cannot be readily cleaned with a solvent such as acetone should be avoided. Polymerization of high viscosity DERMABOND® Adhesive may be accelerated by water or fluids containing alcohol. High viscosity DERMABOND® Adhesive should not be applied to wet wounds. High viscosity DERMABOND® 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 with high viscosity DERMABOND® Adhesive, position the patient so that any run-off of adhesive is away from the eye. The eye should be closed and protected with gauze. Prophylactic placement of petroleum jelly around the eye, to act as a mechanical barrier or dam, can be effective in preventing inadvertent flow of adhesive into the eye. High viscosity DERMABOND® Adhesive will not adhere to skin pre-coated with petroleum jelly. Therefore, avoid using petroleum jelly on any skin area where high viscosity DERMABOND® Adhesive is intended to adhere. Use of DERMABOND® Adhesive near the eye has inadvertently caused some patients eyelids to be sealed shut. In some of these cases, general anesthesia and surgical removal has been required to open the eyelid. High viscosity DERMABOND® Adhesive should not be used below the skin because the polymerized material is not absorbed by tissue and can elicit a foreign body reaction. High viscosity DERMABOND® Adhesive should not be used in high skin tension areas or across areas of increased skin tension, such as knuckles, elbows, or knees, unless the joint will be immobilized during the skin healing period or unless skin tension has been removed by application of another wound closure device (e.g., sutures or skin staples) prior to application of high viscosity DERMABOND® Adhesive. High viscosity DERMABOND® Adhesive treated wounds should be monitored for signs of infection. Wounds with signs of infection, such as erythema, edema, warmth, pain and pus, should be evaluated and treated according to standard practice for infection. High viscosity DERMABOND® Adhesive should not be used on wound sites that will be subjected to repeated or prolonged moisture or friction. High viscosity DERMABOND® adhesive should only be used after wounds have been cleaned, debrided and are otherwise closed in accordance with standard surgical practice. Local anesthetic should be used when necessary to ensure adequate cleansing and debridement. Excessive pressure of the applicator tip against wound edges or surrounding skin can force the wound edges apart and allow adhesive into the wound. Adhesive within the wound could delay wound healing and/or result in adverse cosmetic outcome. Therefore, high viscosity DERMABOND® Adhesive should be applied with a very light brushing motion of the applicator tip over easily approximated wound edges. High viscosity DERMABOND® Adhesive polymerizes through an exothermic reaction in which a small amount of heat is released. With the proper technique of applying high viscosity DERMABOND® Adhesive in multiple thin layers (at least two) onto a dry wound and allowing time for polymerization between applications, heat is released slowly and the sensation of heat or pain experienced by the patient is minimized. However, if high viscosity DERMABOND® Adhesive is applied so that large droplets of liquid are allowed to remain unspread, the patient may experience a sensation of heat or discomfort. High viscosity DERMABOND® Adhesive is packaged for single patient use. Discard remaining opened material after each wound closure procedure. Do not resterilize high viscosity DERMABOND® Adhesive. Do not place high viscosity DERMABOND® Adhesive in a procedure pack/tray that is to be sterilized prior to use. Exposure of high viscosity DERMABOND® 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 its viscosity and may render the product unusable For complete product details, please see Instructions for Use.