MAUDE Adverse Event Report: ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 062943

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ulcer (2274)

Event Date 03/11/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.In (b)(6) 2021, the patient experienced anemia with a hemoglobin level of 4.On (b)(6) 2022, the patient experienced very dark stools / melena and went to the emergency room.While in the emergency room, a physician believed that the patient must be having a low bleeding (located in the lower part of the digestive system) which must have been occurring for some time.The patient also reported having abdominal pain on the left lower abdominal area, tiredness, and constipated for a few days.On (b)(6) 2022, the patient underwent an upper digestive endoscopy which revealed a superficial contact ulcer on d2.A gastroenterologist considered that the ulcer may have occurred due to the introduction of the aspirate (which was introduced by the vascular).It was reported that the ulcer was not bleeding, and the peg/j was maintained and remained in place.The patient was treated with intravenous omeprazole for a few days and switched to oral formulation.The patient was also treated with 3 units of packed red blood cells due to anemia and hemoglobin level of 8.5.It was unknown if the anemia and hemoglobin levels were due to the ulcer.On (b)(6) 2022, the patient was discharged from the hospital and the events of anemia and contact ulcer was unchanged.

Manufacturer Narrative

Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062918.The device involved in the event remained implanted in the patient; therefore, a return sample evaluation is unable to be performed.A gastro-intestinal ulcer is a known complication of a j tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer (Section G): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer Contact: terry ingram ; 1675 lakeside drive; waukegan, IL 60085 ; 8479385350
• MDR Report Key: 14047454
• MDR Text Key: 289082025
• Report Number: 3010757606-2022-00219
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 062943
• Device Lot Number: 32101140
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABBVIE PEG TUBE, LOT # 32195288
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female