On (b)(6) 2018, the following information was reported to kci: the hospital could not provide the prevena¿ 125 therapy unit lot number therefore a device history review could not be performed.Based on the information provided, it cannot be determined that the alleged seroma is related to the prevena¿ 125 therapy unit.Prevena¿ 125 therapy 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.Dressing components: to avoid trauma to the skin, do not pull or stretch the adhesive border of the dressing during application.Dressing application instructions: caution: if the dressing covers the umbilicus, the umbilicus must first be fully filled with an anti-microbial petroleum gauze prior to dressing application.
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On 08 jul 2018, the following information was reported to kci by the hospital: on (b)(6) 2018, a post operative cesarean section patient using the prevena¿ 125 therapy unit with prevena¿ peel and place¿ dressing kit allegedly developed seroma.The patient was sent to the emergency room and underwent an incision and drainage.No additional information is available.The prevena¿ 125 therapy unit lot number was not provided, therefore a device history review could not be performed.
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