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

Catalog Number 062943

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

Patient Problems Ulcer (2274); No Code Available (3191)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062918.The device involved in the event was not returned and remained implanted in the patient; therefore, a return sample evaluation is unable to be performed.  a bezoar and duodenal ulcer are known complications of a j-tube placement.(b)(4).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 (b)(6) 2020, the patient was hospitalized for vomiting and abdominal pain.An x-ray was performed, the connectors were disconnected and the internal tube can be seen.In (b)(6) 2020, a gastroscopy was performed and a bezoar and duodenal ulcer were observed.On (b)(6) 2020, it was reported that duopa therapy has been suspended and the patient returned to oral treatment for parkinson's.

Manufacturer Narrative

Reference record (b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2021, it was reported that the patient remains hospitalized and is receiving unspecified antibiotic therapy for the treatment of duodenal ulcer and bezoar.

• 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: 10968410
• MDR Text Key: 220217622
• Report Number: 3010757606-2020-00768
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

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 Expiration Date: 10/31/2021
• Device Catalogue Number: 062943
• Device Lot Number: 32204238
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 03/05/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBVIE PEG TUBE, LOT # 32023428; ABBVIE PEG TUBE, LOT # 32023428
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR