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 inflammation 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, the patient experienced stoma site purulent, pain, and inflammation.The patient was treated with unknown antibiotic with some improvement.It was reported that the patient is no longer having stoma site pain and redness.
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