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

Catalog Number 062941

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

Patient Problems Sepsis (2067); Skin Infection (4544)

Event Date 10/23/2023

Event Type  Death  

Event Description

On 23 october, patient death was reported from poland by a (b)(6), the causes of death were provided as sepsis, gastrointestinal bleeding, stoma site infection, multiple organ failure, and brain hemorrhage.The patient underwent a procedure for the replacement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube due to leakage and expansion of the stoma site on (b)(6) 2023.It was reported that the patient's j tube was removed, and two stiches were applied.The patient received new pegj tubing in a new stoma site.It was reported that a month following the pegj replacement, the patient was hospitalized and admitted to the icu due to a stoma site infection, sepsis and gastrointestinal bleeding.The patient was administered iv antibiotics for the stoma site infection.During the course of the hospitalization, the patient experienced multiple organ failure, and a brain hemorrhage.The patient had a previous history of peg tube replacements caused by stoma site healing problems.The patient had a medical history of rheumatological disease treated with immunosuppressive steroids, chronic venous insufficiency, and inflammation of the subcutaneous tissue.After multiple query attempts, no further information was available on the cause of the sepsis and gastrointestinal bleeding.It was unknown if an autopsy was performed.

Manufacturer Narrative

Reference record (b)(4).It is unknown if the device involved in the event remained implanted in the patient or was removed; 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.Stoma site infection, and sepsis 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.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE MEDICAL DEVICE CENTRE; 1675 south lakeside drive; waukegan; 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: 18249076
• MDR Text Key: 329507882
• Report Number: 3010757606-2023-00807
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• 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: Female