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 Problem No Code Available (3191)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the similar us list#.The international list number is unknown.(b)(4).The device involved in the event was not returned; therefore a return sample evaluation is unable to be performed.Bezoar is a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

Since (b)(6) 2016, patient in (b)(6) has bee on duopa therapy.On an unknown date, patient underwent procedure for the placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube.It was reported that on (b)(6) 2020, the patient was admitted to the hospital because of a knot at the tip of the tube and enterolith formation.The tube was drawn to the distal small intestine due to intestinal stone formation at the knot.On (b)(6) 2020, the j-tube was removed endoscopically.Additional information received indicates, according to the physician as the knot was formed, food residue was accumulated there, and intestinal stone formation occurred.On (b)(6) 2020, j- tube reinsertion was performed and treatment was continued without problem.

• 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: 10984959
• MDR Text Key: 220713092
• Report Number: 3010757606-2020-00782
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K142816
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• 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: PEG TUBE - MANUFACTURER UNK
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 58