ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
|
Back to Search Results |
|
Catalog Number 062943 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Ulcer (2274); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 11/11/2022 |
Event Type
Injury
|
Event Description
|
On (b)(6) 2021, a patient in italy underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2022, it was reported that the patient experienced duodenal ulcer due to the presence of a phytobezoar.On (b)(6) 2022, the patient expelled the phytobezoar and was discharged.The patient is awaiting tube replacement.
|
|
Manufacturer Narrative
|
Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062918.Bezoar and duodenal ulcer are known complications of a peg- j tube placement.(b)(4).The device involved was not returned; therefore, a return sample evaluation is unable to be performed.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
|
|
Search Alerts/Recalls
|
|
|