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) 2020, 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 in (b)(6) 2020 during a nurse visit, the patient experienced redness around the stoma site with pus discharge and pain upon pressure.The gastroenterologist was informed and one week of antibiotic treatment with ceclor and topical betadine twice daily was commenced.
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