Other serious or important medical events: it is unknown if and what medical or surgical intervention was required.Date of event: the specific date of the event is unknown, therefore (b)(6) 2021 was utilized.The v.A.C.® granufoam¿ dressing identifier was not provided.Based on the information provided, it cannot be determined that the alleged reaction, infection and blood clot are related to the v.A.C.® granufoam¿ dressing.Per the reporting nurse, the reported events were unrelated to the v.A.C.® granufoam¿ dressing; however, this information could not be corroborated by the physician.Kci has made multiple unsuccessful attempts to obtain additional clinical and device information.The v.A.C.® granufoam¿ dressing lot number was not provided and the product was not returned; therefore, a device history record review and device evaluation could not be performed.Device labeling, available in print, states: precautions.Protect periwound skin.Do not allow foam to overlap onto intact skin.Protect fragile/friable periwound skin with additional v.A.C.® drape, hydrocolloid or other transparent film.If a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance/expertise of a specialist: check the therapy hour meter to ensure that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day).If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation.Clean wound more thoroughly during dressing changes.Evaluate for signs and symptoms of infection and, if present, treat accordingly.Change dressing often, ensuring that it is being changed at least every 48 hours.Examine the wound and debride as necessary.Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.Assess for osteomyelitis and, if present, treat accordingly.Clinical considerations: in case of suspect wound deterioration, the lead clinician should be notified, the wound should be clinically examined, and the plan of care reevaluated.The decision to resume v.A.C.® therapy should be made at the discretion of the lead clinician.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.Warnings: with or without using v.A.C.® therapy, certain patients are at high risk of bleeding complications.The following types of patients are at increased risk of bleeding, which, if uncontrolled, could be potentially fatal.Patients who have weakened or friable blood vessels or organs in or around the wound as a result of, but not limited to: suturing of the blood vessel (native anastomosis or grafts)/organ infection.Trauma.Radiation.Patients without adequate wound hemostasis.Patients who have been administered anticoagulants or platelet aggregation inhibitors.Patients who do not have adequate tissue coverage over vascular structures.If v.A.C.® therapy is prescribed for patients who have an increased risk of bleeding complications, they should be treated and monitored in a care setting deemed appropriate by the treating physician.If active bleeding develops suddenly or in large amounts during v.A.C.® therapy, or if frank (bright red) blood is seen in the tubing or in the canister, immediately stop v.A.C.® therapy, leave dressing in place, take measures to stop the bleeding and seek immediate medical assistance.The v.A.C.® therapy units and dressings should not be used to prevent, minimize or stop vascular bleeding.· protect vessels and organs: all exposed or superficial vessels and organs in or around the wound must be completely covered and protected prior to the administration of v.A.C.® therapy.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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