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Under the supervision of a healthcare professional: AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, adhesive and non adhesive may be used for the management of both chronic and acute wounds, such as: - Partial thickness (second degree) burns; - - Diabetic foot ulcers, leg ulcers, (venous stasis ulcers and leg ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness); - Surgical wounds - - Traumatic wounds; - - Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites; - Abrasions; - Lacerations; - Minor Cuts; - Minor scalds and burns.

AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive is a soft, sterile foam wound dressing comprised of a waterproof outer polyurethane film and a multi-layered absorbent pad, with the adhesive dressing having a silicone adhesive border. The multi-layered absorbent pad contains a layer of polyurethane foam and a non-woven wound contact layer of silver Hydrofiber™ (sodium carboxymethylcellulose). The dressing's Hydrofiber™ wound contact layer contains 1.2% w/w ionic silver. The silver in the dressing kills a broad spectrum of wound bacteria held in the dressing. This dressing absorbs high amounts of wound fluid and bacteria and creates a soft, cohesive gel that intimately conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement) without damaging healthy tissue. The outer film layer provides a waterproof viral and bacterial barrier which protects the wound from external contaminants. The film also helps manage the moisture vapor transmission of the exudates absorbed by the dressing AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive may be used as a primary or secondary dressing. It may be used alone or in combination with other wound care products. The adhesive dressing has a silicone border which provides secure, skin friendly adhesion. This conformable and highly absorbent dressing absorbs wound fluids, creating a soft gel which maintains a moist environment. The moist wound environment is known to support the body's healing process.

For Over-the-Counter Use: AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for: - Abrasions - Lacerations - Minor cuts - Minor scalds and burns Under the supervision of a healthcare professional: AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for the management of: - Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection; - Partial thickness (second degree) burns; l AND/OR - Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg . ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness); - Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; - Surgical wounds that heal by primary intent such as dermatological and surgical = incisions (e.g. orthopedic and vascular); - Traumatic wounds; l - Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites; - Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma; - Painful wounds; - Infected wounds

AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber is a one piece wound dressing comprised of two layers of soft, sterile non-woven material. The non-woven pads are comprised of Hydrofiber™ dressing and ionic silver stitchbonded together with regenerated cellulose fibers and designed to provide additional absorbency and tensile strength properties. This conformable and highly absorbent dressing absorbs wound fluids, creating a soft gel which maintains a moist environment and supports the body's healing process.

For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications.

The Flexi-Seal® SIGNAL™ Fecal Management System is comprised of a soft catheter tube assembly, a Luer Syringe, a collection bag with filter and a cinch clamp to pinch off flow in the catheter when required for medication retention. The components are contained in a snap closed tray. The catheter main drain tube is fabricated from collapsible silicone rubber. The drain tube has a low-pressure polyurethane or silicone retention balloon at the distal end and a connector for attaching a collection bag (provided with the device and separately) at the proximal end. There is a recess under the balloon for the clinician's finger allowing the device to be positioned digitally. Two ports are attached to the side of the catheter. One port is used to inflate the retention balloon with water or saline after the device has been inserted into the patient's rectum. This port also provides a visual and tactile signal of when the low pressure retention balloon is filled to its optimal volume. The other port is used to flush the device if needed and administer medication, if prescribed. A syringe (provided with the device) is used to fill and evacuate the retention balloon for insertion and removal. The device, collection bay and syringe are intended for single us, are provided nonsterile, and have no components made with animal products, natural rubber latex or DEHP. This 510(k) concerns modifications to the indications for use, materials and design featured with the predecessor device, the ConvaTec Fecal Management System (ref. K032734).

The VITALA™ Continence Control Device is a single-use device intended to prevent the release of stool from an end colostomy while allowing any flatus from the stoma to be deodorized and released. To be used only with a 1 ¾ in. (45 mm) or 2 ¼ in. (57 mm) ConvaTec NATURA® skin barrier.

The Vitala™ Continence Control Device is a pouchless ostomy device consisting of a self-inflating Air Seal which contacts a stoma and is held against the stoma with a low pressure, allowing flatus to be deodorized and vented while retaining stool. The Air Seal contains a soft foam insert that expands to fill the Air Seal, causing the Air Seal to expand with it. As it expands, the Air Seal gently contacts the stoma and conforms to the shape of the stoma, and is held against the stoma with a low pressure. The Air Seal will re-inflate to remain in contact with the stoma retracts or moves away from the Air Seal. The Vitala™ Continence Control Device also includes an expandable container to collect stool during removal of the device. This single use device is designed to be used only with a 1 ¾" (45mm) or 2 ¼" (57mm) ConvaTec Natura® skin barrier, and will accommodate a range of stoma diameters. This 510(k) notification concerns a design modification for the Vitala™ Continence Control Device to allow its use with ConvaTec Moldable Technology™ skin barriers.

The VITALA™ Continence Control Device is a single-use device intended to prevent the release of stool from an end colostomy while allowing any flatus from the stoma to be deodorized and released. To be used only with a 1 ¾ in. (45 mm) or 2 ¼ in. (57 mm) ConvaTec NATURA® skin barrier. Not intended for use with ConvaTec Moldable Technology™ skin barriers.

The Vitala™ Continence Control Device is a pouchless ostomy device consisting of a self-inflating Air Seal which contacts a stoma and is held against the stoma with a low pressure, allowing flatus to be deodorized and vented while retaining stool. The Air Seal contains a soft foam insert that expands to fill the Air Seal, causing the Air Seal to expand with it. As it expands, the Air Seal gently contacts the stoma and conforms to the shape of the stoma, and is held against the stoma with a low pressure. The Air Seal will re-inflate to remain in contact with the stoma if the stoma retracts or moves away from the Air Seal. The Vitala™ Continence Control Device also includes an expandable container to collect stool during removal of the device. This single use device is designed to be used only with a 1 ½" (45mm) or 2 ¼" (57mm) ConvaTec Natura® skin barrier, and will accommodate a range of stoma diameters. The Vitala™ Continence Control Device is indicated for individuals with end colostomies. The device is not intended for use until the abdomen and peristomal area have fully healed from bowel surgery (typically 6-12 weeks post surgery), or for use with a stoma protrusion greater than 2 cm (when lying down). The device should also not be used in individuals with end colostomies with a history of chronic liquid stool. ConvaTec Moldable Technology™ skin barriers should not be used with the Vitala™ device. This 510(k) notification concerns modification of the labeling for the Vitala™ Continence Control Device to allow an expanded wear time of up to 12 hours per day for the device as well as expanded compatibility with ConvaTec Natura® convex products. Otherwise, the design, materials, and manufacture of the device remain unchanged from its description in 510(k) Premarket Notification K083785, except that its deflation shield is now made from polypropylene.