On an (b)(6) 2021, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube.On (b)(6) 2021, a family member reported that the patient developed a stoma site infection.The patient was treated with an unknown antibiotic for 7 days.
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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 remained implanted in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Stoma site infection 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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