Reference number (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).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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On an unknown date, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.After an unspecified amount of time, the patient experienced skin irritation and granulation with a suspicion of a buried bumper.On (b)(6) 2021, it was reported that a buried bumper was confirmed.On (b)(6) 2021, the peg can move freely and a replacement was scheduled for next months.
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