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 11/01/2021 |
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 disposition of the device involved in the event was unknown; 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 an unknown date, a patient in (country) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.(b)(6) 2021, the patient was admitted to the hospital due to an unspecified complication regarding buried bumper syndrome.On (b)(6) 2021, the peg-j tubing was removed.The tubing was not replaced in order to allow the site of the buried bumper to heal.On (b)(6) 2021, a naso-jejunal tube was placed for duodopa administration.
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