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 Problems Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062910.The device involved in the event was not returned and the device disposition is unknown; therefore, a return sample evaluation is unable to be performed.  a buried bumper and stoma infections are known complication of a peg tube placement.Instructions for use indicates once the stoma site is healed, the abbvie peg tube should be mobilized.Push the abbvie peg tube carefully 3-4 cm into the stoma and move the tube in a bi-directional motion (back and forth) every time the dressing is changed.When doing so the tube should not be turned or rotated under any circumstances to prevent the formation of loops and dislocation of the abbvie j tube.It is important for the tube to move freely in the stoma to prevent the internal retention plate from becoming embedded (¿buried bumper syndrome¿).(b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2018, 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 a buried bumper.On (b)(6) 2020, the patient underwent an endoscopic procedure to remove and replace the peg and pegj tubes.On (b)(6) 2020, it was reported that the patient experienced stoma site complications; inflammation and hypertrophic granulation tissue.The patient is being treated with intravenous pantoprazole 40 mg twice a day, and intravenous antibiotic amoxicillin 1200 mg three times a day for two weeks.

• 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: 10346310
• MDR Text Key: 201348758
• Report Number: 3010757606-2020-00496
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K142793
• 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: 07/14/2020

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: 11/30/2018
• Device Catalogue Number: 062941
• Device Lot Number: 32265205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR