MiroDerm® Biologic Wound Matrix

• Proprietary perfusion decellularization process results in an open collagen matrix with natural vascular pathways to assist in cellular infiltration and integration

MiroDerm® Biologic Wound Matrix is indicated for the management of wounds including partial- and full-thickness wounds; pressure injuries; venous ulcers; chronic vascular ulcers; diabetic ulcers; tunneled, undermined wounds; trauma wounds (abrasions, lacerations, second-degree burns, skin tears); draining wounds; and surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence).

This device is derived from a porcine source and should not be used in patients with known sensitivity to porcine material. This device is not indicated for use in third-degree burns.

• MiroDerm® Biologic Wound Matrix is supplied sterile for single use only. Reuse of a single-use device creates a potential risk of patient user infections and may compromise the device functionality, which may lead to illness or serious injury.
• Do not re-sterilize as the safety and performance have not been evaluated for this scenario.
• Do not use a device past the expiration date, as the safety and performance have not been evaluated.
• Do not use if the package or seal is opened, damaged or compromised and discard all open and unused portions of the device. A damaged package could result in a breach of sterility or device damage.
• Do not use the product if the heat indicator has been activated, as the safety and performance of the device has not been evaluated for that scenario.
• After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state and federal laws and regulations. This is a single-use device. Reuse of this device creates a potential for patient infections.
• Discard device if mishandling has caused possible damage or contamination, as it may have resulted in breach of sterility or compromised device functionality.
• MiroDerm® should be hydrated and moist when the package is opened. If MiroDerm® is dry, do not use as a dry device may impact ease of handling or not conform to the site properly, both impacting desired performance.
• Soak the device for a minimum of two minutes using a sterile basin and room-temperature sterile saline or room-temperature sterile lactated Ringer’s solution to cover the mesh to assist in removing some of the phosphate buffered aqueous solution in which the device is packaged.
• MiroDerm® should not be used until excessive exudate, bleeding and acute swelling are controlled and infections have been cleared as it may not conform to the site properly and not perform as desired.

The following complications are possible. If any of these conditions occur, the device should be removed:
• Infection
• Chronic inflammation (Initial application of wound dressings may be associated with transient, mild, or localized inflammation)
• Allergic reaction
• Excessive redness, pain, swelling or blistering

MiroDerm® (Fenestrated and Fenestrated Plus) is a sterile medical device that should be stored in a clean, dry location at room temperature in its original package. Avoid prolonged exposure to elevated temperatures as it may compromise device functionality. The product expiration date is indicated as year (four digits) and month (two digits). The product expires after the last day of the month indicated.