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 Aspiration/Inhalation (1725); Pneumonia (2011)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(6).Catalog number is the international list number which is similar to us list number of 062912.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.Aspiration pneumonia 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

On (b)(6) 2020, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2020, the physician reported that the patient had experienced aspiration pneumonia and worsening of the general condition since an unknown date.The patient had been hospitalized since (b)(6) 2020 for duodopa titration.The patient received cefrtiaxone 3x2 g intravenous (iv) antibiotic for the aspiration pneumonia.On (b)(6) 2020, the physician reported the patient still has aspiration pneumonia, and the antibiotics were switched to iv piperacillin and iv tazobactan.Additionally, a stroke was confirmed, with the onset being prior to the start of duodopa treatment.

• 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: 10391715
• MDR Text Key: 202416686
• Report Number: 3010757606-2020-00517
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 062945
• Device Lot Number: 32084217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• 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
• Treatment: J-TUBE - UNKNOWN MANUFACTURER AND LOT #
• Patient Outcome(s): Hospitalization; Required Intervention