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 Problems Bowel Perforation (2668); Stomach Ulceration (4488); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/03/2023

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 062918.The device involved in the event was discarded; therefore, a return sample evaluation cannot be performed.H6 code of 4581 was chosen to capture the event of bezoar.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On an unknown date, a patient in greece underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2023 a new jejunal tube was placed.On (b)(6) 2023, a gastroscopy was performed.A bezoar was found along with a buried end of intestinal tube peripyloric.The jejunal tube was removed.For an unknown reason, a new peg tube was also placed at the time of the gastroscopy.The patient was to receive per os treatment for parkinsons and omeprazole.

Event Description

Additional information received on 03 oct 2023: patient additionally experienced and ulcer near the jejunum and for that reason only the peg tube was replaced on (b)(6) 2023.The patient was treated with omeprazole.

• 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: 17634086
• MDR Text Key: 322089666
• Report Number: 3010757606-2023-00596
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062943
• Device Lot Number: 32061422
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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: UNKNOWN PEG TUBE, UNKNOWN LOT#
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male