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 Problems
Aspiration/Inhalation (1725); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/19/2021 |
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 was not returned and remained implanted in the patient; therefore, a return sample evaluation is unable to be performed.Aspiration pneumonia 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) 2021, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube.On (b)(6) 2021, the patient experienced a 38c fever and was diagnosed with aspiration pneumonia in the emergency department.(b)(4) has not initiated at the time of reporting.The patient has been discharged from the hospital.
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