(b)(4).Catalog number is the international list number which is similar to us list number of 062912.The device involved in the event remained implanted in the patient; 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) 2019, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On an unknown date in (b)(6) 2019, the patient experienced buried bumper syndrome.It was reported that no clinical intervention was performed at the time the buried bumper was discovered, due to the clinical condition of the patient.No further information was available.
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