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

Catalog Number 062910

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

Patient Problem Skin Infection (4544)

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).Catalog number in d4 is the similar us list number; the international list number is unknown.The device manufacturer and lot number of the device involved in this complaint was not provided.Therefore, it is unknown if the device involved was abbvie branded tubing.Conservatively, abbvie has chosen to report this complaint due to the potential that the device involved could have been abbvie branded tubing.The device involved in the event remained implanted in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Stoma site infection is a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On an unknown date, a patient in the united kingdom underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube.In (b)(6) 2023 the patient stoma site was red with oozing.A culture was done and the patient was prescribed an unspecified antibiotic and topical cream.At the time of report, the stoma site was looking better.

• 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: 18344391
• MDR Text Key: 330804723
• Report Number: 3010757606-2023-00827
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/08/2023

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 Catalogue Number: 062910
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female