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 was discarded; therefore, a return sample evaluation is unable to be performed.(b)(4).A buried bumper 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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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.In (b)(6) 2021, the patient experienced difficulty in mobilizing the peg tube in and out of the stoma.On an unknown date, the patient was diagnosed with a buried bumper.On (b)(6) 2021, the peg-j tubing was replaced, and the buried bumper was resolved.
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