MAUDE Adverse Event Report: MEDTRONIC, INC. VENASEAL GLUE; AGENT, OCCLUSION, VASCULAR, PERMANENT

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

Patient Problems Pain (1994); Swelling (2091); Pressure Sores (2326)

Event Date 07/05/2018

Event Type  Injury  

Event Description

Had a vein closure procedure on (b)(6) 2018.The physician used venaseal to seal veins.Within a week, had to go to hosp for ultrasound due to pain in r-leg upper thigh.Called dr a week later because leg was weak and swollen, was prescribed steroids.Did not improve and was prescribed antibiotic.Continued to deteriorate.Developed 9 open sores with shards of glue seeping from wounds.Surgery to remove glue and vein.

• Brand Name: VENASEAL GLUE
• Type of Device: AGENT, OCCLUSION, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 8042489
• MDR Text Key: 126544644
• Report Number: MW5081096
• 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: Patient
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 51