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3DMax™ Synthetic mesh 3DMax™ Mesh

3DMax™ Mesh, Medium Right, 8.5 cm x 13.7 cm (3 in x 5 in)

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Overview

A clinically proven fixation-free product for laparoscopic approaches such as TAPP, TEP and Robotic TAPP

The 3DMax™ Mesh was developed based on careful and precise anatomical research of the inguinal canal. The three-dimensional, anatomically curved shape, sealed edge and medial orientation marker allow for easier positioning than a conventional flat mesh and also enhance the speed and simplicity of placement.1

 

 

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Features and Benefits
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References

1. Bell, Price. “Laparoscopic Inguinal Hernia Repair Using an Anatomically Contoured Three-Dimensional Mesh.” Surgical Endoscopy. 2003:17:1784-1788.

2. Koch et al. “Randomized Prospective Study of Totally Extraperitoneal Inguinal Hernia Repair: Fixation Versus No Fixation of Mesh.” Journal of the Society of Laparoendoscopic Surgeons. 2006:10:457-460.

Indications

Bard 3DMax™ mesh is indicated to reinforce soft tissue where weakness exists, e.g., for repair of hernia and chest wall defects.

Contraindications

Literature reports that there may be a possibility for adhesion formation when Bard 3DMax™ mesh is placed in direct contact with the bowel or viscera. Do not use Bard 3DMax™ mesh in infants and children, whereby future growth will be compromised by use of such material.

Warnings

The use of any permanent mesh or patch in a contaminated or infected wound could lead to fistula formation and/or extrusion of the prosthesis. If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device.

Precautions

Do not cut or reshape the Bard 3DMax™mesh as this may affect its effectiveness. If fixation is used, care should be taken to ensure that the mesh is adequately fixated to the abdominal wall. If necessary, additional fasteners and/or sutures should be used. If sutures are used to secure the mesh in place, nonabsorbable monofilament sutures are recommended.

Adverse Reactions

Possible complications include seromas, 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

00801741030758

1


Quantity

1/cs.


Dimensions

Medium, Right 3DMax™ Mesh, 3" x 5" (8.5cm x 13.7cm)

GTIN

GTIN - Case 00801741030758 1

Packaging

Quantity 1/cs.

Product Basic Specification

Dimensions Medium, Right 3DMax™ Mesh, 3" x 5" (8.5cm x 13.7cm)
References
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Electronic Instructions for Use (eIFUs)
Resources
References
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Frequently Asked Questions
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References
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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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