Reference record (b)(4).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.Catalog number is the international list number which is similar to us list number of 062910.Stoma site infection is a known complication of a peg tube/ 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) 2022, a patient in greece 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 discharge and irritation.On an unknown date, it was found that the patient had large discharge of fluids at the stoma site, and hardness and local irritation at the stoma site with pain to the left and above the stoma site.The patient was prescribed augmentin 625 mg 3 times per day for the stoma site.
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