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 easily crack 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 6 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: Each tube is intended for single patient use. The product will not polymerize in the dauber and harden like most products currently do, allowing derma+flex® QS™ to be used over multiple incisions on the same patient during the same procedure if necessary. Any remaining adhesive left inside the delivery device once the procedure is over should be appropriately discarded.

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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