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The v.A.C.® dressing lot number was not provided, and the dressing was not returned; therefore, a device history record review and a device evaluation could not be performed based on information provided, it cannot be determined that the alleged bleeding event is related to the v.A.C.® dressing.Device labeling, available in print and online, states: contraindications do not place foam dressings of the v.A.C.® therapy system directly in contact with exposed blood vessels, anastomotic sites, organs, or nerves.Warnings bleeding: 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.Always ensure that v.A.C.® foam dressings do not come in contact with vessels or organs.Use a thick layer of natural tissue should provide the most effective protection.If a thick layer of natural tissue is not available or is not surgically possible, multiple layers of non-adherent dressing material may be considered as an alternative, if deemed by the treating physician to provide a complete protective barrier.If using non-adherent materials, ensure they are secured in a manner that will maintain their protective position throughout therapy.Dressing changes wounds being treated with the 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 no less than 3 times a week, with frequency adjusted by the clinician 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; the dressing changing intervals should be based on a continuing evaluation of the 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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On (b)(6) 2022, the following information was provided to kci by the patient: v.A.C.® therapy was placed on hold and patient went to the hospital allegedly due to irritation and bleeding around periwound area.The patient believed that v.A.C.® dressing may have been rubbing against healthy skin and created the issue.He is now home and resumed the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Skin preparation is now being used in area for protection and the nurse is careful to avoid v.A.C.® dressing from rubbing any healthy tissue.The patient stated the area is looking better and therapy has been resumed.On (b)(6) 2022, the following information was provided to kci by the home health case manager: the home health nurse removed the v.A.C.® dressing on (b)(6) 2022 and applied pressure.The mother called the physician, and the patient was transported to the emergency room via ambulance.The physician contacted the surgeon, and the patient was transported to the hospital.On (b)(6) 2022, the following information was provided to kci by the home health nurse: the bleeding occurred with the removal of the v.A.C.® dressing and was cauterized after the patient was transported via ambulance to the hospital.She stated the patient received a blood transfusion; however, did not have specifics as the patient was admitted to a hospital and did not have access to medical records.The v.A.C.® 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.
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