ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
|
Back to Search Results |
|
Catalog Number 062941 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Skin Infection (4544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 02/19/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
Reference number (b)(4).Catalog number in d4 is the international list number which is similar to us list number of 062910.The device involved in the event was discarded and was not returned; therefore, a return sample evaluation is unable to be performed.Stoma site infection and buried bumper are known complications of a peg- j tube placement.H6 code of 4581 was chosen to capture the event of buried bumper syndrome.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
|
|
Event Description
|
On (b)(6) 2021, a patient in germany underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.From (b)(6) to (b)(6) 2024, the patient was hospitalized due to stoma inflammation.He was given oral antibiotics.The peg tube had grown in from the inside.
|
|
Search Alerts/Recalls
|
|
|