Potential Complications - COOK Medical OASIS Mode D'emploi

• OASIS ECM is sterile if the package is dry, unopened and
undamaged. Do not use if the package seal is broken.
• OASIS ECM must be used prior to the expiration date.
• Discard OASIS ECM if mishandling has caused possible
damage or contamination.
• OASIS ECM should not be applied until excessive exudate,
bleeding, acute swelling, and infection is controlled.
• No studies have been conducted to evaluate the
performance of OASIS ECM in pediatric populations or in
patients who are pregnant.

POTENTIAL COMPLICATIONS

The following complications are possible. If any of these
conditions occur, the device should be removed.
• Allergic reaction
• Blistering
• Infection
• Inflammation (Initial application of wound dressings may
be associated with transient, mild, localized inflammation.)
• Pain
• Redness
• Swelling
STORAGE
Store OASIS ECM in a clean, dry location at room temperature.
STERILIZATION
OASIS ECM has been sterilized with ethylene oxide.
INSTRUCTIONS FOR USE
NOTE: Always handle the OASIS ECM using aseptic technique.
1. Prepare the wound area using standard of care methods
to ensure wound is free of debris and necrotic tissue. If
necessary, surgically debride and treat the wound bed
with standard of care techniques to ensure the wound
shows granulation tissue and the edges contain viable
tissue.
2. Trim the OASIS ECM to the appropriate size based on
the size of wound area, ensuring that the graft covers
the entire wound surface area and extends slightly
beyond the wound margins. If the wound is larger than a
single sheet, then multiple sheets may be used. Overlap
adjoining sheets to provide coverage of the entire wound.
3. Apply the OASIS ECM in its dry state over the wound.
Hydrate the device with sterile saline or lactated Ringer's
solution. Alternatively, hydrate the OASIS ECM by placing
it in a basin with sterile saline or lactated Ringer's solution
prior to placing it over the wound. A hydration time of
greater than 1 minute is not required.
4. Verify that the OASIS ECM extends beyond the margins
of the wound to obtain the appropriate overlap. Smooth
the OASIS ECM into place to ensure the sheet is in contact
with the underlying wound bed. User may secure the
graft with preferred method of fixation.
5. Apply a porous, non-adherent dressing over the OASIS
ECM and affix using method of choice.
NOTE: A non-adherent dressing will help secure and protect
the OASIS ECM during secondary dressing changes, while also
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