FREQUENTLY ASKED QUESTIONS

Q: Has derma+flex® QS™ been cleared by the FDA?

A: Yes, derma+flex® QS™ has been cleared by the FDA as a Class II medical device.

Q: What are the advantages of derma+flex® QS™ over what I currently use?

A: Current butyl monomer products are brittle.1 These products tend to crack easily and slough off especially in areas that require skin movement and flexibility.1 Butyl products have been around since the mid 1970’s. The current market leading 2-Octyl monomer product requires an external initiator to make the adhesive polymerize (dry).1 These initiators cause a reaction resulting in increased heat to the wound site.1 This makes application of the adhesive on patients with trauma injuries more uncomfortable.2

derma+flex® QS™ is not brittle but is flexible and does not use an external initiator. As a result it does not burn and can be used on most skin surfaces of the body with the exception of high tension areas that may require sutures, staples, or adhesive strips.

derma+flex QS is meant for external dermal application only and should not contact the eyes. derma+flex® QS™ can be used in conjunction with the noted closure devices in high tension areas to provide added closure and protection against water thus allowing the patient to shower.2

Q: What is the shelf life of derma+flex® QS™?

A: Currently the shelf life is 18 months from date of manufacture but additional studies are ongoing to increase the shelf life.1

Q: How many times can you use a derma+flex® QS™ tube?

A: derma+flex® QS™ may be used multiple times on a single patient undergoing a single procedure.

Caution: Federal law restricts this device to sale by or on the order of a physician.

1 Data on File. Chemence Medical Products, Inc.
2 Quinn, J; Tissue Adhesives in Clinical Medicine, Second Edition (BC Decker Inc, 2005)

 

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