Avitene™ Microfibrillar Collagen Hemostat is an active absorbable collagen hemostat, proven to accelerate clot formation. Avitene™ effectively enhances platelet aggregation and the release of proteins to form fibrin, resulting in hemostasis.
FORMATS VARIÉS ADAPTÉS À CHAQUE SPÉCIALITÉ :
Disclaimers
Not all products, services, claims or features of products may be available or valid in your local area. Please check with your local BD representative.
Please consult product labels and instructions for use for indications, contradictions, hazards, warnings, and precautions.
Indications
Avitene™ Ultrafoam™ sponge is indicated in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Contradictions
Avitene™ Ultrafoam™ sponge should not be used in the closure of skin incisions as it may interfere with the healing of the skin edges. This is due to simple mechanical interposition of dry collagen and not due to any intrinsic interference with wound healing.
It has been reported with other collagen hemostatic agents, that by filling porosities of cancellous bone, they may significantly reduce the bond strength of methylmethacrylate adhesives. Avitene™ Ultrafoam™ sponge should not, therefore, be employed on bone surfaces to which prosthetic materials are to be attached with methylmethacrylate adhesives.
Warnings
Avitene™ Ultrafoam™ sponge is inactivated by autoclaving.
Ethylene oxide reacts with bound hydrochloric acid to form ethylene chlorohydrin.
This device has been designed for single use only. Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material 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. Opened, unused product should be discarded.
As with any foreign substance, use of Avitene™ Ultrafoam™ sponge in contaminated wounds may enhance infection.
Avitene™ Ultrafoam™ sponge should not be used in instances of pumping arterial hemorrhage.
It should not be used where blood or other fluids have pooled, or in cases where the point of hemorrhage is submerged as it may mask an underlying source of bleeding, resulting in hematoma.
Avitene™ Ultrafoam™ sponge will not act as a tampon or plug in a bleeding site, nor will it close off an area of blood collecting behind a tampon.
Avitene™ Ultrafoam™ sponge is not intended to treat systemic coagulation disorders.
Not for injection, intraocular or intravascular use.
Adverse Reactions
The most serious adverse reactions reported, which may be related to the use of other collagen products, are potentiation of infection including abscess formation, hematoma, wound dehiscence and mediastinitis.
Other reported adverse reactions possibly related are adhesion formation, allergic reaction, foreign body reaction and subgaleal seroma (report of a single case), and increased incidence of alveolalgia when used for packing of dental extraction sockets.
Disclaimers
Not all products, services, claims or features of products may be available or valid in your local area. Please check with your local BD representative.
Please consult product labels and instructions for use for indications, contradictions, hazards, warnings, and precautions.
Indications
Avitene™ Ultrafoam™ sponge is indicated in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Contradictions
Avitene™ Ultrafoam™ sponge should not be used in the closure of skin incisions as it may interfere with the healing of the skin edges. This is due to simple mechanical interposition of dry collagen and not due to any intrinsic interference with wound healing.
It has been reported with other collagen hemostatic agents, that by filling porosities of cancellous bone, they may significantly reduce the bond strength of methylmethacrylate adhesives. Avitene™ Ultrafoam™ sponge should not, therefore, be employed on bone surfaces to which prosthetic materials are to be attached with methylmethacrylate adhesives.
Warnings
Avitene™ Ultrafoam™ sponge is inactivated by autoclaving.
Ethylene oxide reacts with bound hydrochloric acid to form ethylene chlorohydrin.
This device has been designed for single use only. Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material 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. Opened, unused product should be discarded.
As with any foreign substance, use of Avitene™ Ultrafoam™ sponge in contaminated wounds may enhance infection.
Avitene™ Ultrafoam™ sponge should not be used in instances of pumping arterial hemorrhage.
It should not be used where blood or other fluids have pooled, or in cases where the point of hemorrhage is submerged as it may mask an underlying source of bleeding, resulting in hematoma.
Avitene™ Ultrafoam™ sponge will not act as a tampon or plug in a bleeding site, nor will it close off an area of blood collecting behind a tampon.
Avitene™ Ultrafoam™ sponge is not intended to treat systemic coagulation disorders.
Not for injection, intraocular or intravascular use.
Adverse Reactions
The most serious adverse reactions reported, which may be related to the use of other collagen products, are potentiation of infection including abscess formation, hematoma, wound dehiscence and mediastinitis.
Other reported adverse reactions possibly related are adhesion formation, allergic reaction, foreign body reaction and subgaleal seroma (report of a single case), and increased incidence of alveolalgia when used for packing of dental extraction sockets.
BD-119790
Références
