| The FDA said: "This is to alert you to deaths and serious complications, especially bleeding and infection, associated with the use of Negative Pressure Wound Therapy, or NPWT, systems, and to provide recommendations to reduce the risk. Although rare, these complications can occur wherever NPWT systems are used, including acute and long-term healthcare facilities and at home. FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years...In the last two years, FDA received six death and 77 injury reports associated with NPWT systems. Most of the deaths reported to FDA occurred at home or in a long-term care facility. Bleeding was the most serious complication and was reported in six death and 17 injury reports." Kinetic Concepts (KCI) offers a wide range of clinically proven, economically beneficial wound healing therapies and technologies designed to deliver positive outcomes for patients and healthcare professionals. Reference Link :theflyonthewall.com |
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