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

Catalog Number 062910

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

Patient Problems Pneumonia (2011); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/13/2022

Event Type  Death  

Manufacturer Narrative

Reference number (b)(4).Catalog number is the similar us list number, the international list number is unknown.The device manufacturer and lot number of the device involved in this complaint was not provided.Therefore, it is unknown if the device involved was abbvie branded tubing.Abbvie has chosen to report this complaint due to the potential that the device involved could have been abbvie branded tubing.The disposition of the device involved is unknown; therefore, it is unknown if a return sample evaluation is able to be performed.(b)(4).Complaint reviewed by mdr team and medical qa physicians.While it is not specified that the patient experienced an aspiration pneumonia, due to the timing of the event in relation to the endoscopy performed for the buried bumper, a relationship between the two events cannot be ruled out.Further, this is an elderly patient with a history of stroke and a diagnosis of parkinson's disease for over 20 years, which also predispose this patient to aspiration pneumonia.Conservatively, and with an abundance of caution this event is being reported.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On an unknown date, a patient in hungary underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2022, the patient noticed that the inner support plate of the peg tube could not be moved and on (b)(6) 2022 a buried bumper was diagnosed.The patient was admitted to the hospital.On (b)(6) 2022 an endoscopy was performed, but it was not successful in alleviating the buried bumper.The patient was admitted to the surgical unit of the hospital and surgery was scheduled.On (b)(6) 2022, the patient passed away, the cause of death was pneumonia.

• 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: 15219575
• MDR Text Key: 297820444
• Report Number: 3010757606-2022-00531
• 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: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062910
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: J-TUBE UNKNOWN MANUFACTURER, UNKNOWN LOT#
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male