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 not returned; 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) 2017, a patient in romania underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2019, the patient underwent endoscopy for an unspecified reason.During the procedure, a buried bumper was discovered.The physician attempted to remove the internal bumper but was unsuccessful.The patient was sent to surgery to remove the peg tube, but it was unknown if the peg tube was successfully removed.
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