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

Catalog Number 062945

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

Patient Problems Death (1802); Pneumonia (2011); Sepsis (2067)

Event Date 02/01/2019

Event Type  Death  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062910.The device involved in the event remained implanted in the patient and was not returned for evaluation; therefore a return sample evaluation was not performed.Bleeding and pneumonia are known complications of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

Since (b)(6) 2019, patient in (b)(6) was in the hospital to be medicated with duopa.On (b)(6) 2019, patient underwent procedure for placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube.It was reported that the puncture site was bleeding after the procedure and was sutured.Patient remained hospitalized.Physician reported that since (b)(6) 2019, the patient had sepsis and suspected pneumonia.On (b)(6)2019, pneumonia was confirmed and patient was diagnosed with myocardial infarction.The patient was transferred to intensive care unit.Additional information indicated that on (b)(6) 2019, the patient died as a result of pneumonia, sepsis, and ileus in the hospital.

• 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: 8434513
• MDR Text Key: 139285360
• Report Number: 3010757606-2019-00182
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 062945
• Device Lot Number: 32041156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR