Adverse Reactions - Synovis Peri-Guard Mode D'emploi

WARNINGS:
The Rinse Procedure must be followed or a sterile inflammatory reaction in
the adjoining host tissue may result. Do not pour the storage solution into
the rinse bath.
To avoid damage to the product, do not expose to any chemicals or
substances other than those specified in this Rinse Procedure. Antimycotics
must not come in contact with Peri-Guard as they are believed to alter the
cross-link characteristics of tissue fixed in aldehyde preparations.
Do not freeze. Damage may result. Do not use if freeze indicator is
activated.
Do not resterilize. Do not subject to steam, gas (ethylene oxide), or
radiation sterilization as these may damage Peri-Guard.
Do not use if the container is not properly sealed prior to opening, as
sterility may be compromised. Do not place container in sterile field as the
outside of the container is not sterile. This product is for single use only.
Once the container seal is broken, use immediately, do not reseal container
or reuse Peri-Guard. Any unused pieces of Peri-Guard must be discarded.
Failure to observe these warnings may result in surgical infection.
Complete heart block and complete right bundle heart block have been
reported for procedures involving cardiac repair near the atrial-ventricular
conduction bundles, most notably for repair of atrial septal defects.
Clinical experience with glutaraldehyde fixed porcine xenograft heart
valves indicates that fixed tissue may be subject to late attack by the body
and subsequent tissue deterioration. In a like manner, the glutaraldehyde
fixed bovine pericardium may be subject to late deterioration. The benefits
of the use of this tissue in cardiovascular repair or repair of soft tissue
deficiencies must be weighed against the possible risk of aneurysm or
hemorrhage or patch weakening resulting from tissue deterioration.
PRECAUTIONS:
Rinse surgical gloves to remove glove powder prior to touching Peri-Guard.
Before surgery, prospective patients or their representatives should be
informed about complications which may be associated with use of this
product. As with any surgical procedure, dehiscence at the surgical site and
infection are possible complications. Monitor patient for infection and take
appropriate therapeutic action.

ADVERSE REACTIONS:

Failure to rinse the product may result in a sterile inflammatory reaction
(see Warnings and Rinse Procedure).
The effect on long term surgical outcome of damaging bovine pericardium
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