Reference number (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; therefore, a return sample evaluation is unable to be performed.Stoma site infection is a known complication of a peg- j 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.After an unspecified amount of time, the patient experienced pain and inflammation around the stoma with some exudate and was diagnosed with a stoma site infection.The event was treated with amoxycillin.
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