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 was not returned and remained implanted in the patient; 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) 2020, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2020, the patient experienced redness around the stoma site with smelling exudate.A culture swab of the stoma site was collected and was positive for (b)(6) and blood test resulted in increased crp level.The patient remained hospitalized and was treated with topical isobetadine, oral augmentin, and intravenous vancomycin antibiotics.There is suspicion of septicemia following a (b)(6) infection located at the stoma level.The patient was discharged from the hospital on (b)(6) 2020.
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