3M™ Prevena™ Incision Management System

System Kit: dressing, pump, canister, carrying case. 5 pack of dressings. A la carte: 5 pack of dressings, 5 pack canisters, single pack pump.

3M™ Prevena™ 125 and 3M™ Prevena Plus™ 125 Therapy Units manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed compatible dressings, 3M™ Prevena™ 125 and 3M™ Prevena Plus™ 125 Therapy Units are intended to aid in reducing the incidence of seroma in patients at high risk for post-operative infections and aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.

Contraindicated for patients with a sensitivity to silver.

Before applying the 3M™ Prevena™ Incision Management System to patients who are at risk of bleeding complications due to the operative procedure or concomitant therapies and/or co-morbidities, ensure that homeostasis has been achieved and all tissue planes have been approximated. If active bleeding develops suddenly or in large amounts during therapy, or if frank blood is seen in the tubing or canister, the patient should leave the Incision dressing in place, turn off Therapy Unit and seek immediate emergency medical assistance. As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection or other complications. Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge, or strong odor. Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock, and/or fatal injury. Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension, or erythroderma (a sunburn-like rash). Silver in the interface layer of the Incision Dressing is not intended to treat infection, but to reduce bacterial colonization in the fabric. If infection develops, therapy should be discontinued until the infection is treated. Remove the Incision Dressing if defibrillation is required in the area of the dressing placement. Failure to remove the dressing may inhibit transmission of electrical energy and/or patient resuscitation. The 3M™ Prevena™ Incision Management System is MR Unsafe. Do not take the Therapy Unit into the MR environment. The Incision Dressing can typically remain on the patient with minimal risk in an MR environment. Interruption of Therapy during an MRI may reduce the effectiveness of therapy. The Incision Dressing should pose no known hazards in an MR environment with the following conditions of use: static magnetic field of 3 Tesla or less, spatial gradient field of 720 Gauss/cm or less, and maximum whole-body-averaged specific absorption rate (SAR) of 3W/kg for 15 minutes of scanning. The Incision Dressing contains metallic silver that may impair visualization with certain imaging modalities. Do not take the 3M™ Prevena™ Incision Management System or Incision Dressing into a hyperbaric oxygen chamber; it is not designed for this environment and should be considered a fire hazard. If therapy is reinitiated after HBO treatment, do not readhere the same dressing; a new dressing must be reapplied. If at any time while using the 3M™ Prevena™ Incision Management System, the canister becomes full of fluid other than blood, indicated by a Maximum Capacity Alert or visual inspection, the patient should turn therapy unit off and contact the treating physician.

Allergic Response: The Incision Dressing has an acrylic adhesive coating and a skin interface layer with silver, which may present a risk of an adverse reaction in patients who are allergic or hypersensitive to acrylic adhesives or silver. If a patient has a known allergy or hypersensitivity to these materials, do not use the 3M™ Prevena™ Incision Management System. If any signs of allergic reaction, irritation, or hypersensitivity develop, such as redness, swelling, rash, urticaria, or significant pruritus, patient should consult a physician immediately. If bronchospasm or more serious signs of allergic reaction appear, the patient should turn off the therapy unit and seek immediate emergency medical assistance.