Miro3D Wound Matrix Safety and Risk Information

CONTRAINDICATIONS

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.

WARNINGS

  • Miro3D is supplied sterile for single use only. Reuse of a single-use device creates a potential risk of patient or user infections and may compromise the device functionality, which may lead to illness or serious injury.
  • Do not resterilize, as the safety and performance has not been evaluated for this scenario. This is a single-use device. Reuse of this device creates a potential risk of patient infections.
  • Do not use a device past the expiration date as the safety and performance has not been evaluated for this scenario.
  • Do not use if the package or seal is opened, damaged, or compromised. A damaged package could result in a breach of sterility or device damage, which may lead to illness or serious injury.
  • 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 risk of patient infections.

PRECAUTIONS

  • Discard device if mishandling has caused possible damage or contamination as it may have resulted in breach of sterility or compromised device functionality.
  • Soak the device for a minimum of 5 minutes using a sterile basin and room temperature sterile saline or room temperature sterile lactated Ringer’s Solution to allow for desired conformity of the product to the wound site.
  • Miro3D 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.

POTENTIAL ADVERSE EVENTS

  • Allergic reaction
  • Excessive redness, pain, swelling, or blistering
  • Fever
  • Infection
  • Chronic Inflammation
  • Non-healing wound

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SM-00250 Rev. A 02/23