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 Gastrointestinal Hemorrhage (4476); Stomach Ulceration (4488)

Event Date 10/23/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a patient in italy underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2022, the patient experienced a gastric hemorrhage caused by the presence of a gastric ulcer.It was reported that duodopa therapy was suspended.It was reported that the physician has no information about the location of the gastric ulcer and treatment provided to address the reported issue.No further information is available.

Manufacturer Narrative

Reference record (b)(4).It is unknown if the device involved in the events was removed and discarded or is still in place; therefore, a return sample evaluation is unable to be performed.Catalog number is the international list number which is similar to us list number of 062910.Gastro intestinal ulcer and gastric hemorrhage 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: 16208950
• MDR Text Key: 307730834
• Report Number: 3010757606-2023-00046
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• 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: 12/27/2022
• 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 J-TUBE, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male