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

Catalog Number 062903

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

Patient Problems Gastritis (1874); Ulcer (2274); Swelling/ Edema (4577)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).The device involved in the event was discarded; therefore, a return sample evaluation is unable to be performed.A gastro-intestinal ulcer is a known complication of an nj tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6)2021, a patient in (b)(6) underwent a procedure for the placement of naso-jejunal (nj) tube.The nj tube was removed on (b)(6) 2021.On (b)(6) 2021.During the endoscopy procedure to insert peg-j tubing, an esophageal ulcer was discovered, along with gastritis.The physician stated that the esophageal ulcer could have been caused by the nj tube.On (b)(6) 2021, the patient was seen by an ear, nose, and throat physician.It was found that the patient had swelling in the uvula.The patient remained hospitalized after the procedure and was treated with sucralfate 4x1 oral medication for gastritis and the esophageal ulcer, a proton pump inhibitor for gastritis, and dexamethasone iv for swelling in uvula.The cause for the swelling of the uvula was unknown.The patient was discharged from the hospital on (b)(6) 2021.

• 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: 12460318
• MDR Text Key: 271040695
• Report Number: 3010757606-2021-00619
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K142792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2022
• Device Catalogue Number: 062903
• Device Lot Number: 1111947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR