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.From (b)(6) 2020 to (b)(6) 2020, the patient experienced abdominal and stoma site pain that was relieved with citodon (codiene) and alvedon (paracetamol) one tablet three times a day.On (b)(6) 2020, the patient experienced redness around the stoma.The patient is being treated with heracillin (flucloxacillin) 1,000 mg three times a day for ten days.The stoma site has recovered and peg mobilization is unremarkable.
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