MAUDE Adverse Event Report: MEDTRONIC IRELAND VERASEAL GLUE ; AGENT, OCCLUDING, VASCULAR, PERMANENT

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

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Impaired Healing (2378)

Event Date 11/05/2019

Event Type  Injury  

Event Description

I had a vein procedure done on (b)(6) 2019.The opening would never heal.I had discharge and granules oozing from my leg.Eventually my vein developed sore every inch or so up my leg.I&d culture showed pseudomonas.Hospitalized twice for iv antibiotics and debridement surgery.Eventually i had to have a picc line inserted and administered abx 3 times a day.Fda safety report id# (b)(4).

• Brand Name: VERASEAL GLUE
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 9763586
• MDR Text Key: 181629342
• Report Number: MW5093315
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 73