On (b)(6) 2020, a patient in germany underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.In 2023, the patient's stoma was inflamed and the patient had received several courses of antibiotics.In nov 2023, the stoma site was slightly reddened.
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Reference number (b)(4).Catalog number in d4 is the international list number which is similar to us list number of 062910.The device involved in the event remained in the patient and was not returned; therefore, a return sample evaluation cannot 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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