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

Catalog Number DUODOPA INTESTINAL TUBE

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

Patient Problem Peritonitis (2252)

Event Date 06/21/2021

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).The device involved in the event remained implanted in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Peritonitis is a known complication of a peg tube/ j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

During the week of (b)(6) 2021, a patient in the (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.Approximately one week later, the patient experienced abdominal complaints, stoma site redness with pus, and loose fixation plate.The patient was admitted to the gastroenterology department and diagnosed with peritonitis, which was treated with unspecified antibiotics.On an unknown date, the patient experienced increased stoma site secretions and was treated with another round of unspecified antibiotic.In (b)(6) 2021, it was reported that the insertion site was calm and the peritonitis had resolved.

• 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: 12189644
• MDR Text Key: 262239233
• Report Number: 3010757606-2021-00497
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DUODOPA INTESTINAL TUBE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/19/2021
• 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: ABBVIE J-TUBE, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR