3M™ Prevena Restor™ Incision Management System

Before applying the 3M™ Prevena Restor™ 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 3M™ Prevena Restor™ 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 Prevena Restor™ Dressing is not intended to treat infection, but to reduce bacterial colonization in the fabric. If infection develops, Prevena Restor™ Therapy should be discontinued until the infection is treated. Remove the Prevena Restor™ 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. All therapy units, including the 3M™ Prevena™ Plus 125 Therapy Unit, are MR unsafe. Do not take therapy units into the MR environment. The Prevena Dressings can typically remain on the patient with minimal risk in an MR environment. Interruption of Prevena Restor™ Therapy during MRI may reduce the effectiveness of the 3M™ Prevena Restor™ Incision Management System. The Prevena Dressings 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 Prevena Restor™ Dressing contains metallic silver that may impair visualization with certain imaging modalities. Do not take therapy units or Prevena Restor™ Dressings into a hyperbaric oxygen chamber. They are not designed for this environment and should be considered a fire hazard. If Prevena Restor™ 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 Prevena Restor™ Incision Management System the canister becomes full of fluid, indicated by a therapy unit alert or visual inspection, the patient should turn off the therapy unit and contact the treating physician for additional instruction.