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

Catalog Number 062918

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

Patient Problems Death (1802); Bowel Perforation (2668)

Event Date 08/01/2019

Event Type  Death  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the similar us list number, the international list number is unknown.The device involved in the event was discarded was not returned; therefore, a return sample evaluation is unable to be performed.Bowel perforation 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 percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On an unknown date, the patient experienced abdominal pain.On an unknown date, the patient had an unspecified surgery for the abdominal pain.The patient recovered from the surgery, but another unspecified abdominal surgery was necessary.However, the patient declined to proceed with an additional surgery.The patient passed away on (b)(6) 2019, possibly due to a bowel perforation as a result of the peg-j placement.The exact cause of death was 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: 8926738
• MDR Text Key: 155394438
• Report Number: 3010757606-2019-00576
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K142816
• 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: 08/01/2019

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: Health Professional
• Device Catalogue Number: 062918
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/23/2019
• 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
• Treatment: UNKNOWN PEG TUBE -LOT # UNKNOWN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 82 YR