MAUDE Adverse Event Report: VENASEAL OR SAPHEON ; AGENT, OCCLUDING, VASCULAR, PERMANENT

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

Patient Problems Death (1802); Erythema (1840); Swelling (2091)

Event Date 09/11/2019

Event Type  Death  

Event Description

Pt received venaseal vein and endovascular ambulatory care center on (b)(6) 2019.Pt was admitted to (b)(6) on (b)(6) 2019 with blisters and redness over extremity that was treated.Over the course of several weeks, physicians diagnosed possible nicolau syndrome secondary to biomedical glue injection outside of hospital.Fda safety report id# (b)(4).

• Brand Name: VENASEAL OR SAPHEON
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• MDR Report Key: 9290648
• MDR Text Key: 165568319
• Report Number: MW5090924
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 11/05/2019

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Disability
• Patient Age: 83 YR
• Patient Weight: 89