On (b)(6) 2022, the following information was provided to kci by the physician: on (b)(6) 2022, the prevena plus¿ incision management system was applied post-operatively.On (b)(6) 2022, the device was removed at the end of therapy.Upon removal, it was noted that part of the epidermis had allegedly necrotized, and the physician believed this was due to the use of the prevena plus¿ incision management system as the necrosis was only on the surface.The necrotic tissue was treated with sharp debridement and an unspecified cream.No further information provided.The prevena plus¿ incision management system was discarded; therefore, a device evaluation could not be performed.A device history record review for the prevena plus¿ incision management system lot number a01292v009 was completed.All end release testing of product and packaging met specifications.
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The prevena plus¿ incision management system was discarded; therefore, a device evaluation could not be performed.Based on the information provided, it cannot be determined that the alleged necrosis requiring debridement and application of a cream is related to the prevena plus¿ incision management system.All end release testing of product and packaging met specifications.Device labeling, available in print and online, states: the prevena plus¿ incision management system will not be effective in addressing complications associated with: ischemia to the incision or incision areas, untreated or inadequately treated infection, inadequate hemostasis of the incision, cellulitis of the incision area.The prevena plus¿ incision management system should be used with caution in the following patients: patients with fragile skin surrounding the incision as they may experience skin or tissue damage upon removal of the prevena¿ dressing.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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