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 spain underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On an unknown date, the patient was evaluated by the physician who diagnosed a stoma site infection.The patient was prescribed unknown antibiotics for the stoma site infection.It was reported that the patient's stoma site improved following antibiotic treatment, however signs of infection have presented again.The patient will have a stoma site culture done.
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