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

Catalog Number DUODOPA PEG TUBE

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

Patient Problems Skin Infection (4544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).The device involved in the events remained implanted in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.A buried bumper and stoma site infection are known complications of a peg tube placement.(b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2017, a patient in the (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2021, the patient's spouse reported that prior to a scheduled tubing replacement, an x-ray revealed that the retention disc was inside of the abdominal tissue and the patient was diagnosed with buried bumper syndrome and cellulitis with drainage on a section of the skin on the stoma.The patient was diagnosed with buried bumper syndrome and was treated with oral clindamycin, topical lotrimin and cortisone cream.A tubing replacement is scheduled for (b)(6) 2021.

• 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: 13028746
• MDR Text Key: 283093373
• Report Number: 3010757606-2021-00834
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DUODOPA PEG TUBE
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: No
• 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:LOT # UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male