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
Peritonitis (2252); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/06/2021 |
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 was discarded; therefore, a return sample evaluation is unable to be performed. peritonitis and post-op wound infection are known complications 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 with jejunal (peg-j) tube.On an unknown date, the patient experienced altered general condition.On (b)(6) 2021, the patient was diagnosed with clostridium difficile infection and peritonitis.On (b)(6) 2021 the patient underwent a surgical procedure for the removal of the peg-j system to promote local healing.The patient remains hospitalized in serious condition.
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Search Alerts/Recalls
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