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

Catalog Number 062943

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

Patient Problem Pneumonia (2011)

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062918.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.Pneumonia is a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2021, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic jejunal tube (j-tube).The nurse reported that the patient was hospitalized for duodopa therapy titration.It was unclear if the underwent a peg tube placement prior to the j tube placement.On an unknown date, the patient was relocated to the medicine ward due to a pneumonia infection.Due to the infection, the nurse stated that the duodopa therapy did not really work as the patient was blocked and only the eyes followed the visitor, with no verbal communication or spontaneous movement.The patient's general condition was bad and the patient was treated with unknown intravenous kefzol.The nurse stated that the patient "had been already in poor general condition before the start of duodopa therapy".At the time of report, the patient was in an unstable condition.

• 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: 12823592
• MDR Text Key: 280949722
• Report Number: 3010757606-2021-00796
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062943
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: No
• 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: PEG TUBE, UNKNOWN MANUFACTURER
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male