PACKAGE INSERT INFORMATION
NOTICES: PLEASE READ INSTRUCTIONS COMPLETELY BEFORE USING

THIS MATERIAL SHOULD NOT BE RE STERILIZED IN ANY FASHION PRIOR TO INSERTION.

THIS MATERIAL IS INTENDED FOR THE TREATMENT OF ONE PATIENT IN A SINGLE APPLICATION ONLY.

DESPITE RIGOROUS DONOR SCREENING EVALUATION, AND PROCESSING, THIS TISSUE MAY TRANSMIT INFECTIOUS AGENTS. REPORT ANY SUSPECTED DISEASE TRANSMISSION TO FASCIA BIOSYSTEMS, CUSTOMER SERVICE.

DO NOT USE IF THE PACKAGE IS PERFORATED OR THE SYRINGE SEAL IS BROKEN. STORE AT ROOM TEMPERATURE. DO NOT FREEZE OR REFRIGERATE. CONTACT FASCIA BIOSYSTEMS REGARDING THE RETURN POLICY. OPENED OR DAMAGED GOODS WILL NOT BE ACCEPTED FOR RETURN.

THIS MATERIAL HAS BEEN PROCESSED IN ACCORDANCE WITH SPECIFIC FDA GUIDELINES FOR ITS PRODUCTION AS WELL AS THE GUIDELINES 62FR40429.

USE OF THIS MATERIAL IS AT THE SOLE DISCRETION AND JUDGEMENT OF THE INDIVIDUAL PRACTITIONER. FASCIA BIOSYSTEMS, LLC, MAKES NO CLAIMS REGARDING THE BIOLOGICAL OR BIOMEDCHANICAL PROPERTIES OF THE PROVIDED ALLOGRAFT. FASCIA BIOSYSTEMS, LLC, CANNOT ASSUME RESPONSIBILITY FOR ANY MISUSE OF ALLOGRAFTS PROVIDED FOR CLINICAL APPLICATION.

CAUTION:

FEDERAL LAW RESTRICTS THE SALE DISTRIBUTION AND USE OF THIS MATERIAL TO THE ORDER OF LICENSED PHYSICIANS, PODIATRISTS, AND ORAL-MAXILLOFACIAL SURGEONS.

DESCRIPTION:

This package contains HUMAN ALLOGRAFT MATERIAL specifically fascia , collected from human cadaver donors. Donor suitability was determined by the appropriate bank according to the standards of the American Association of tissue Banks (MTB) and FDA. Donor serum was negative by FDA-licensed tests for human immunodeficiency virus antibody (anti-HIV 1-2), Hepatitis B surface antigen (HBsAG), Hepatitis B core antibody (HBcAB), Hepatitis C antibody (anti HCV), human T-lymphotropic virus type I antibody (anti HTLV-1), and rapid plasma reagin (RPR) for syphilis. The material has been freeze-dried, irradiated, particulated, and vacuum-sealed. Technical details of processing are available on request.

HOW SUPPLIED:

Fascian™ is particulate fascia that has been prepackaged and vacuum-sealed in a 3cc luer-lock syringe. Fascia Biosystems, LLC, distributes six preparations:

1. less than(<) 2.0mm particle size
2. less than(<) 1.0 mm particle size
3. less than (<) 0.5 mm particle size
4. less than (<) 0.25 mm particle size
5. less than (<) 0.10 mm particle size
6. less than (<) 0.08 mm particle size

Check package label to accurately identify the preparation.

CAUTION:

Trace amounts of polymyxin B sulfate, bacitracin and/or gentamicin may be present. Recipients who may be allergic to these antibiotics should be managed accordingly.

DIRECTIONS:

1. The package is labeled with the tissue number, expiration date, quantity, and particle size. Please complete and return mail the enclosed TRANSPLANT RECORD card at the time of transplant.
   
   At the time of implantation, the following information should also be recorded in office records: the date and time of rehydration, the diluent and volume of tissue rehydration fluid, the date and time of implantation, the name of the recipient, site of implantation, and the date and signature of the person recording the information.
   
   
2. Mark the area to be treated.



3. Cleanse and sterilize the overlying skin surface and recipient site.



4. Anesthetize the recipient area as needed. An initial injection with a Solution of 0.5% lidocaine with 1:100000 epinephrine through a 30 gauge needle is suggested, followed by a repeat injection with 1% lidocaine five minutes later to complete anesthesia.



5. Open the Fascian™ box and remove the syringe. If the contents are discolored, e.g. yellow, brown, DO NOT USE.



6. OBSERVE STERILE TECHNIQUE in the handling of the implant. Wear sterile gloves before opening. Remove the syringe seal and tip, and attach an appropriate needle onto the syringe.



7. Rehydrate by aspirating sterile normal saline, 0.5% lidocaine, or a similar injection solution into the syringe. Typically, 2-3 ccs of fluid is adequate. Agitate and allow adequate time, to fully suspend and hydrate the Fascian™.



8. Regarding injection:
   
   1. Fascian™ is a thick suspension and occasional clogging in the needle hub may occur. If clogging occurs, reaspirate 1-2 ccs of saline or change the needle.
   
   
   
   2. Concealed puncture sites, e.g. creases or transnasal, are preferred.
   
   
   
   3. Subdermal injection is advised. Intradermal injection may produce lumpiness and a persistent inflammatory response.
   
   
   
9. After injection, compress the area firmly for 10 minutes to minimize bruising. Keep the area of injection elevated. Cold compresses may be continued for 1-2 hours after injection.



10. Some graft reabsorption may be anticipated. However, overcorrect judiciously, since reabsorption may be slow, especially in areas of thin skin.



11. Discard unused material.

LIMITED WARRANTY:

Fascia Biosystems, LLC, warrants that reasonable care was taken in the manufacture and production of this product, Because Fascia Biosystems, LLC, has no control over the conditions of use, patient selection, surgical procedure, post-surgical stresses, or handling of the material after it leaves our possession, Fascia Biosystems, LLC, does not warrant either good effect or ill effect following its use. Fascia Biosystems, LLC, shall not be responsible for any incidental or consequential loss, damage, or expenses directly or indirectly arising from use of this product. Fascia Biosystems, LL's SOLE responsibility in the event Fascia Biosystems, LLC, determines the product was defective when shipped by Fascia Biosystems, LLC, shall be replacement of the product. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for use. ©1999 FASCIA BIOSYSTEMS, LLC, 9663 Santa Monica Blvd., PMB 840 Beverly Hills, CA 90210 U.S.A.