Technical Information
PosiSep Intranasal Splints are currently only available in the U.S.
Indication:
PosiSep is indicated for use as an intranasal splint intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. PosiSep is constructed of a patient-comfortable sponge which is manufactured from naturally occurring Chitosan polymers.
Instructions:
1. Peel open PosiSep pouch and remove intranasal splint using sterile technique to maintain product integrity.
2. Insert PosiSep longitudinally and apply to area of treatment. For added support, PosiSep may be inserted using a bayonet forceps with tips of the forceps advanced to the leading edge of the intranasal splint.
3. If foam is broken during insertion, assess if size is appropriate for application. If not, dispose and reapply PosiSep.
4. PosiSep is dissolvable and any residual PosiSep that has not dissolved or left the surgical site through normal outflow passages can be removed with irrigation and aspiration.
5. Discard any unused product after opening.
Contraindications:
PosiSep should not be used on patients who have known allergies to shellfish.
Warnings & Precautions:
• Sterility not guaranteed if package is damaged or opened. Discard damaged or open packages.
• Single Use Only.
• To prevent product contamination prior to application, always follow aseptic techniques.
• Contains chitin from shellfish.
• In rare instances, the physiochemical condition associated with nasal surgery, both with and without nasal packing, may present a risk of toxic shock syndrome (TSS).
• Appropriate treatment to be instituted in case of infection.
• In the case of prolonged bleeding seek medical attention.
• Do Not Ingest.
• Do Not Inhale.
• Do not use after the end of the year and month shown.
Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. For detailed information regarding indications for use, warnings and precautions, see Instructions for Use.
Content taken from 50057 Rev. B
