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

Catalog Number 062941

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).Catalog number in d4 is the international list number which is similar to us list number of 062910.The device involved in the event was not returned remained implanted in the patient was discarded; therefore, a return sample evaluation is unable to be performed.A buried bumper is a known complication of a peg tube placement.Health effect clinical code of 4581 was chosen to capture the event of buried bumper.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2020 a patient in israel underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube.In nov 2023 the patient experienced stoma site pain.During a visit, the patient did not have pain but the peg tube was unable to move in or out and the patient was diagnosed with buried bumper syndrome.It was unknown if the buried bumper syndrome was confirmed via diagnostic tests.It was reported that the patient did not receive any pharmacological or invasive interventions and a tubing replacement was scheduled.No further information was available.

• 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: 18351946
• MDR Text Key: 330816284
• Report Number: 3010757606-2023-00857
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K142793
• 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: 11/19/2023

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: 062941
• Device Lot Number: 32195288
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2023
• Initial Date FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2018
• 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: J TUBE, UNKNOWN MANUFACTURER
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Female