Medela Invia White Foam Mode D'emploi page 8

complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, faint-
ing, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory
and/or orthostatic hypotension, or erythroderma (a sunburn-like rash).
If there are any signs of the onset of systemic infection or advancing infection at the
wound site, contact a physician immediately to determine if therapy should be discon-
tinued.
Osteomyelitis: The therapy system should NOT be initiated on a wound with untreated
osteomyelitis. Consideration should be given to thorough debridement of all necrotic, nonviable
tissue, including infected bone (if necessary), and appropriate antibiotic therapy.
Protect tendons, ligaments and nerves: Tendons, ligaments and nerves should be protected
to avoid direct contact with foam dressings. These structures may be covered with natural
tissue, meshed non-adherent material, or bioengineered tissue to help minimize risk of
desiccation or injury.
Foam placement: Always use White Foam from sterile packages that have not been opened
or damaged. Do not place any foam pieces into blind/unexplored tunnels. Do not force foam
dressings into any area of the wound, as this may damage tissue, alter the delivery of negative
pressure, or hinder exudate and foam removal. Always count the total number of pieces of
foam used in the wound and document that number on the transparent film and in the patient's
chart. Also document the dressing change date on the transparent film.
Foam removal: Invia White Foam is not bioabsorbable. Always count the total number of
pieces of foam removed from the wound and ensure the same number of foam pieces
was removed as placed. Foam left in the wound for greater than the recommended time
period may foster ingrowth of tissue into the foam, create difficulty in removing foam from the
wound, or lead to infection or other adverse events. Regardless of treatment modality, disrup-
tion of new granulation tissue during any dressing change may result in bleeding at the wound
site. Minor bleeding may be observed and considered expected. However, patients with
increased risk of bleeding, as described in the Warnings section under Bleeding, have a poten-
tial for more serious bleeding from the wound site.
If significant bleeding develops, immediately discontinue the use of the therapy system,
take measures to stop the bleeding and do not remove the foam dressing until the treat-
ing physician or surgeon is consulted. Do not resume the use of the therapy system until
adequate hemostasis has been achieved and the patient is not at risk of continued
bleeding.
Acrylic adhesive: The Invia Transparent Film has an acrylic adhesive coating, which may
present a risk of an adverse reaction in patients who are allergic or hypersensitive to acrylic
adhesives. If a patient has a known allergy or hypersensitivity to such adhesives, do not use
the therapy system. If any signs of allergic reaction or hypersensitivity develop, such as
redness, swelling, rash, urticaria, or significant pruritus, discontinue use and consult a physi-
cian immediately. If bronchospasm or more serious signs of allergic reaction appear, seek
immediate medical assistance.
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