(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 and was discarded; therefore, a return sample evaluation is unable to be performed. a buried bumper is a known complication of a peg tube placement.(b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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On (b)(6) 2018, 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 reported experienced a buried bumper.The patient is scheduled to have peg ang peg-j tube replacement on (b)(6) 2019 and will continue to receive oral therapy until replacement is complete.
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