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 Problem Bowel Perforation (2668)

Event Date 09/16/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 a patient in the usa underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube and percutaneous endoscopic jejunal tube (j-tube).On (b)(6) 2022 the patient experienced severe pain after flushing the tubing.The patient went to the emergency room and a ct scan revealed a punctured bowel.The patient underwent emergency surgery in which the punctured bowel section was removed and the tubing was pulled out and replaced with a feeding tube to give crushed levodopa/carbidopa tablet and other medications.The patient was not told the location or cause of the bowel puncture (or if had to do with the peg and j tube placement or if the physician punctured the bowel).At the time of report, the patient was in rehab with symptoms of hallucinations.Duodopa therapy had not started.

Manufacturer Narrative

Reference record (b)(4).The device involved in the event was discarded; therefore, a return sample evaluation is unable to be performed.A bowel perforation is a known complication of a peg 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 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: 15611489
• MDR Text Key: 301818240
• Report Number: 3010757606-2022-00665
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/29/2023
• Device Catalogue Number: 062910
• Device Lot Number: 32141120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2020
• 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 # 32481331.
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male