• Intended to be used for the histologic sampling of visually apparent wounds at the wound base, or wound-associated lesions in clinical situations where brush-biopsy curettage specimens would be desired in contrast to a deep, single punch biopsy specimen or fluid collection or cytological swab sampling for anatomic, culture, or molecular pathologic testing

Soft Biopsy® is for use during the care of an external skin wound, biopsy of the wound bed post-debridement or on areas of the wound suspicious for pathology where tangential curettage specimens would be diagnosed using anatomic, microbiology, or molecular pathologic technologies.

Soft Biopsy® is contraindicated for use with patients with known bleeding disorders or those on anticoagulant therapy, patients with an acute wound infection or condition that is not amenable to biopsy, patients with a known allergy to nylon or acrylic plastic, or patients who are pregnant or suspected to be pregnant when a wound biopsy would not be indicated. This device is not conditioned for debridement and should be limited to biopsy only.

• Avoid contact with alcohol or alcohol containing solutions, as they may adversely affect the integrity of the pad adhesion to the plastic tip of the device.
• Avoid application of pressure beyond full compression of the Kylon® fabric as seen visually (visually apparent flattening of the hooks until they lay parallel to the base of the platform), as this will not improve performance, and may cause mechanical failure of the device.
• This is a single-use sterile disposable device and should not be used at multiple sites to avoid cross-contamination by organisms in diagnostic use.

None known

Consult manufacturer on special storage requirements outside of normal room temperatures.