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 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.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 experienced peristomal irritation and bad smelling suppuration from the stoma.The peg tube was only able to be moved circularly.The stoma was disinfected and a sterile bandage applied.On (b)(6) 2019, the patient was diagnosed with a buried bumper and hospitalized.On (b)(6) 2019, the peg tube was surgically removed.
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