ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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Catalog Number 062941 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/03/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 remained implanted in the patient; 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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Event Description
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On (b)(6) 2020, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube.On (b)(6) 2021, the patient experienced pain on mobilization and cannot mobilize normally.The probes are permeable and duodopa therapy passes normally.The nurse suspected a buried bumper and a gastroscopy was scheduled.On an unknown date, a gastroscopy revealed an invagination of the bumper in the gastric mucosa.It was reported that it was impossible to extract the buried bumper without a scalpel and the gastroenterologist did not want to use a scalpel; which indicated the responsibility of surgery.Surgical consult was requested.The patient had no pain.
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