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); Hypovolemic Shock (1917); Respiratory Distress (2045)

Event Date 06/18/2019

Event Type  Death  

Manufacturer Narrative

Reference record (b)(4).The device involved in the event was not available or discarded; therefore, a return sample evaluation is unable to be performed.However, if the device is received, a follow up report will be submitted upon completion of the return sample investigation.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 experienced respiratory distress and hemodynamic shock.On (b)(6) 2019, the patient was treated with hypnovel.On (b)(6) 2019, the patient died.It was reported that the cause of death was hemodynamic shock and respiratory distress.Prior to the placement of the nj tube, the condition of the patient was deteriorating.It is unknown if an autopsy was performed.

• 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: 8875506
• MDR Text Key: 153720822
• Report Number: 3010757606-2019-00545
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062903
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 73 YR