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 Problems Death (1802); Pneumonia (2011)

Event Date 03/06/2019

Event Type  Death  

Manufacturer Narrative

Reference number (b)(4).The device involved in the event remained in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Pneumonia as a post procedure complication is a known complication of a peg- j 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 nasal jejunostomy (nj) tube.On (b)(6) 2019, the patient experienced pneumonia.The treatment was unknown.

Manufacturer Narrative

Reference record (b)(4).

Event Description

On (b)(6) 2019, peg/j tubing was implanted.The physician reported that the patient died on (b)(6) 2019.The cause of death was unknown.

Manufacturer Narrative

Reference record # (b)(4).Additional information in event.

Event Description

On (b)(6)2019 , a doctor reported that the patient had been transfered today to the intensive care unit due to pneumonia.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• MDR Report Key: 8438084
• MDR Text Key: 139377275
• Report Number: 3010757606-2019-00184
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K142792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2020
• Device Catalogue Number: 062903
• Device Lot Number: 1085275
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/21/2019; 03/26/2019
• Supplement Dates FDA Received: 03/28/2019; 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBVIE PEG TUBE, LOT # 3223428; CONCOMITANT PRODUCTS NOT REPORTED; CONCOMITANT PRODUCTS NOT REPORTED
• Patient Outcome(s): Required Intervention