Reference record (b)(4).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) 2019, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On an unknown date, the patient experienced a stoma site infection.A swab was taken of the stoma, with results unknown.The stoma site infection was treated with 2 rounds of unspecified oral antibiotics, the first of which was started on (b)(6) 2019.
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