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

Catalog Number 0AV063

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

Patient Problem Ulcer (2274)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

Reference number (b)(4).Catalog number in d4 is the international list number which is similar to us list number of 062918.The device involved in the event was not returned; therefore, a return sample evaluation is unable to be performed.Duodenal ulcer 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) 2022, a patient in greece underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.After an unspecified amount of time, during gastroscopy, the gastroenterologist found no ulcer in the stomach but in the anterior and upper duodenum bulb.The old intestinal tube was removed because it would deteriorate the ulcer in the duodenum bulb.The patient was not hospitalized.

• 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: 15945928
• MDR Text Key: 305142422
• Report Number: 3010757606-2022-00802
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/08/2022

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: 02/29/2024
• Device Catalogue Number: 0AV063
• Device Lot Number: 32381270
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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, UNKNOWN MANUFACTURER
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female