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

Device Problem Contamination (1120)

Patient Problems Unspecified Infection (1930); Sepsis (2067); Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

Acinetobacter baumannii septic thrombophlebitis, concern for contaminated venaseal product.Fda safety report id# (b)(4).

• Brand Name: VENASEAL
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 14565945
• MDR Text Key: 293281193
• Report Number: MW5110006
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White