Contraindications - Bard soft Mesh Gebrauchsanweisung

B
Large Pore Monofi lament Polypropylene
for the Reconstruction of Tissue Defects
Instructions for Use
Product Description:
B Soft Mesh has a large pore design and is constructed of
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ARD
knitted polypropylene monofi laments. The knit construction allows
the mesh to be stretched in both directions to accommodate and
reinforce tissue defects. B
prosthesis.
Indications:
B Soft Mesh is indicated to reinforce soft tissue where weak-
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ness exists, e.g., repair of hernias and chest wall defects.

Contraindications:

1. Do not use B
ture growth will be compromised by use of such mesh material.
2. Literature reports that there may be a possibility for adhesion
formation when the polypropylene mesh is placed in direct con-
tact with the bowel or viscera.
Warnings:
1. This device must be sterile before use. Please inspect the
packaging to be sure it is intact and undamaged.
2. This device is for single use only. Do not resterilize or reuse
any portion of B
3. Reuse, reprocessing, resterilization or repackaging may
compromise the structural integrity and/or essential mate-
rial and design characteristics that are critical to the overall
performance of the device and may lead to device failure
which may result in injury to the patient.
Reuse, reprocessing, resterilization or repackaging may
also create a risk of contamination of the device and/or
cause patient infection or cross infection, including, but
not limited to, the transmission of infectious diseases from
one patient to another. Contamination of the device may
lead to injury, illness, or death of the patient or end user.
4. Careful attention to B
and suture technique is most important in the presence of
known or suspected wound contamination or infection.
5. The use of any permanent mesh or patch in a contaminated
or infected wound could lead to fi stula formation and/or
extrusion of the prosthesis.
6. If an infection develops, treat the infection aggressively.
Consideration should be given regarding the need to re-
move the mesh. An unresolved infection may require re-
moval of the device.
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Soft Mesh is a nonabsorbable, sterile
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Soft Mesh in infants or children, in whom fu-
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Soft Mesh.
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Mesh
Soft Mesh handling, fi xation,