Reference record (b)(4).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) 2015, a patient underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On an unknown date, the patient was scheduled to have a j-tube replacement, and it was discovered that the patient had buried bumper syndrome.The physician was unable to remove the peg tube, as it was buried too deep.A new peg-j was inserted in a new stoma site.The peg tube with the buried bumper is expected to be removed at a later date.
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