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

Catalog Number 062903

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

Patient Problem Pneumonia (2011)

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).The device involved in the event was discarded; therefore, a return sample evaluation is unable to be performed.Pneumonia is a known complication of a naso-jejunal tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2019, a patient in (b)(6) underwent a procedure for the placement of naso jejunal (nj) tube.On (b)(6) 2019, the patient pulled the nasal tube; as a result, the patient developed a "bad" pneumonia and dysphagia.Duodopa therapy was discontinued and treatment of the pneumonia and swallowing disorders were unknown.

• 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: 8628501
• MDR Text Key: 145662951
• Report Number: 3010757606-2019-00333
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/22/2020
• Device Catalogue Number: 062903
• Device Lot Number: 1085275
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• 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): Other