Based on the information provided, it cannot be determined that the alleged yeast infection requiring medication is related to the v.A.C.® drape.The patient has known sensitivities to adhesives.A device evaluation and a device history record review could not be performed.Device labeling, available in print and online, states: warnings infected wounds: infected wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds, dependent upon factors such as wound conditions and treatment goals.Refer to dressing application instructions (found in v.A.C.® dressing cartons) for details regarding dressing change frequency.As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection, worsening 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).If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact the treating physician immediately to determine if v.A.C.® therapy should be discontinued.Acrylic adhesive and silicone layer: the v.A.C.® drape has an acrylic adhesive coating, which may present a risk of an adverse reaction in patients who are allergic or hypersensitive to acrylic adhesives.The dermatac drape has an acrylic adhesive coating and a silicone layer, which may present a risk of an adverse reaction in patients who are allergic or hypersensitive to acrylic adhesives or silicone.If a patient has a known allergy or hypersensitivity to such materials, do not use the v.A.C.® therapy system.If any signs of allergic reaction or hypersensitivity develop, such as redness, swelling, rash, urticaria or significant pruritus, discontinue use and consult a physician immediately.If bronchospasm or more serious signs of allergic reaction appear, seek immediate medical assistance.Precautions the v.A.C.® therapy system will not be effective in addressing complications associated with the following: - ischemia to the incision or incision area - untreated or inadequately treated infection - inadequate hemostasis of the incision - cellulitis of the incision area v.A.C.® dressing general guidelines dressing changes wounds being treated with the 3m¿ v.A.C.® therapy system should be monitored on a regular basis.In a monitored, non-infected wound, v.A.C.® dressings should be changed every 48 - 72 hours but not less than three times per week, with frequency adjusted by the healthcare practitioner as appropriate.Infected wounds must be monitored often and very closely.For these wounds, dressings may need to be changed more often than 48 - 72 hours taking into account local and systemic signs of infection.The dressing change intervals should be based on a continuing evaluation of wound condition and the patient's clinical presentation, rather than a fixed schedule.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a kinetic concepts, inc.Product malfunctioned, is defective or has caused serious injury.
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