Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062910.The device involved in the event remained implanted in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Stoma site infection is a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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On (b)(6) 2021, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.In (b)(6) 2021, the patient was diagnosed with a fungal infection in the stoma.It was previously treated with topical positon and diclofenac ointments.On an unknown date, a stoma culture was taken, which was positive for candida.The stoma infection was then treated with oral fluconazole.
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