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Composix™ Synthetic mesh Composix™ L/P Mesh

Composix™ L/P Mesh with Introducer Tool, Ellipse, 10.2 in x 13.2 in (26.1 cm x 33.7 cm)

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Overview

A low-profile, large pore polypropylene/ePTFE prosthesis for laparoscopic ventral hernia repair.

The Composix™ L/P Mesh is a lightweight, low profile prosthesis that fits easily through a trocar and offers a permanent barrier that is designed to minimize visceral attachment. The parietal side of the Composix™ L/P Mesh features large pore, lightweight polypropylene Bard™ Soft Mesh which encourages rapid tissue ingrowth for a strong repair while leaving less foreign material in the body. The visceral side features Bard® submicronic permanent ePTFE barrier with over 12 years of clinical success in minimizing tissue attachment.

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Features and Benefits
Promotional Story
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References

INDICATIONS

Bard™ Composix™ L/P Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

CONTRAINDICATIONS

Literature reports there may be a possibility for adhesion formation when the polypropylene is placed in direct contact with the bowel or viscera. Do not use the Bard™ Composix™ L/P Mesh in infants or children whereby future growth will be compromised by use of such material.

Do not use Bard™ Composix™ L/P Mesh for the reconstruction of cardiovascular defects.

PRECAUTIONS

Davol fixation devices or nonabsorable monofilament sutures are recommended to properly secure the prosthesis. If other fixation devices are used, they must be indicated for use in hernia repair. Care should be taken to ensure that the prosthesis is adequately fixated to the abdominal wall. If necessary, additional fasteners and/or sutures should be used.

WARNINGS

Ensure proper orientation; the solid white surface (ePTFE) must be oriented against the bowel or sensitive organs. Do not place the polypropylene mesh surface against the bowel. There may be a possibility for adhesion formation when polypropylene mesh is placed in direct contact with the bowel or viscera.

ADVERSE REACTIONS

Possible complications include seroma, adhesions, hematomas, inflammation, extrusion, fistula formation and recurrence of the hernia or soft tissue defect.

Please consult package insert for more detailed safety information and instructions for use.

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Specification

GTIN - Case

00801741031243

1


Quantity

1/cs


Dimensions

10.2" x 13.2" (26.1cm x 33.7cm) Elliptical with Introducer Tool

GTIN

GTIN - Case 00801741031243 1

Packaging

Quantity 1/cs

Product Basic Specification

Dimensions 10.2" x 13.2" (26.1cm x 33.7cm) Elliptical with Introducer Tool
References
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Electronic Instructions for Use (eIFUs)
Resources
References
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Frequently Asked Questions
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Product Complaints
North American Regional Complaint Center
1-844-8BD-LIFE (1-844-823-5433)
Things to Consider

If you are a patient or end user, you can contact us yourself, or you may have your caregiver or your physician do that for you. To help us process your
information quickly and effectively, please contact our customer complaints
team.

To better facilitate our investigation, please include the following information in your reporting:


  • Product Name and/or Catalog Number
  • Lot Number or Serial Number
  • Any injuries and/or Harm?
  • What is the issue you experienced?
  • Is the actual sample or sample representative available? (If possible, please send affected sample)
  • Contact name and phone number
References
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