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Ventrio™ Synthetic mesh Ventrio™ Hernia Patch

Ventrio™ Hernia Patch

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Overview

Easy. Efficient. Proven.

The Ventrio™ Hernia Patch’s unique design and technique offer patients the benefits of an intraabdominal repair, while offering surgeons the ease of an open anterior approach, with the added ability to use mechanical fixation. The parietal side is constructed of two layers of monofilament polypropylene mesh, providing rapid tissue ingrowth and strong incorporation into the abdominal wall. The visceral side is made of submicronic ePTFE, which provides a permanent barrier minimizing tissue attachment.1

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Features and Benefits
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Specification

GTIN - Case

00801741016387

1

Quantity

1/cs

Dimensions

Small Oval with ePTFE 3.1" x 4.7" (8cm x 12cm)

GTIN

GTIN - Case 00801741016387 1

Packaging

Quantity 1/cs

Product Basic Specification

Dimensions Small Oval with ePTFE 3.1" x 4.7" (8cm x 12cm)
Electronic Instructions for Use (eIFUs)
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Product Complaints
North American Regional Complaint Center
1-844-8BD-LIFE (1-844-823-5433)
productcomplaints@bd.com
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

1 Data generated in preclinical model. Data may not correlate to performance in humans.

2 Majercik, S. et al. “Strength in tissue attachment to mesh after ventral hernia repair with synthetic composite mesh in a porcine model.” Surg Endosc (2006) 20: 1671-1674.

INDICATIONS

The Ventrio™ Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

CONTRADICTIONS

Literature reports that there may be a possibility for adhesion formation when the polypropylene is placed in contact with the bowel or viscera.

WARNINGS

1. Do not cut or reshape the Ventrio™ Hernia Patch, as this could affect its effectiveness. Care should be taken not to cut or nick the SorbaFlex™ PDO monofilament. If the SorbaFlex™ PDO monofilament is cut or damaged during insertion or fixation, additional complications may include bowel or skin perforation and infection.

2. Follow proper folding techniques for all patches as described in the Instructions for Use as other folding techniques may compromise the SorbaFlex™ PDO monofilament.

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

ADVERSE REACTIONS

Possible complications include seroma, adhesions, hematomas, inflammation, extrusion, fistula formation, infection, allergic reaction, and recurrence of the hernia or soft tissue defect. If theSorbaFlex™ PDO monofilament is cut or damaged during insertion or fixation, additional complications may include bowel or skin perforation and infection.

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

BD-16948

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