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

Catalog Number 062941

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

Patient Problems Peritonitis (2252); Aspiration Pneumonitis (4455); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).The device involved in the event was removed from the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Catalog number in d4 is the international list number which is similar to us list number of 062910.H6 code of 4581 was chosen to capture the event of buried bumper syndrome.Aspiration pneumonia, buried bumper syndrome, and peritonitis are known complications of a peg tube/ j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2019, a patient in hungary underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2023, the patient was hospitalized due to the internal retention plate migrating into the stomach wall.On (b)(6) 2023, the patient underwent surgery for the buried bumper syndrome and the patient's tubing was removed, and duodopa therapy was suspended.On (b)(6) 2023, the patient was discharged from the hospital.It was reported that following the hospital discharge, the patient developed fever, pneumonia and peritonitis due to which the patient was hospitalized on (b)(6) 2023.On (b)(6) 2023, the patient underwent surgery for the inflammation of the peritoneum, and was transferred to the icu.

• 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: 18346052
• MDR Text Key: 330731837
• Report Number: 3010757606-2023-00852
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K142793
• 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: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062941
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 11/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN J-TUBE, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male