(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 and not returned; therefore, a return sample evaluation is unable to be performed.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) 2017, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2019, it was discovered during gastroscopy, that the patient had a buried bumper.On (b)(6) 2019, the peg-j tubing was replaced.The patient had been hospitalized since an unknown date for a pulmonary embolism when the buried bumper was discovered.The hospitalization was not device related.
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