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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/06/2022

Event Type  Injury  

Event Description

Had minor surgery to remove varicose vein on (b)(6) 2022.The vascular surgeon used a procedure called venaseal which is the injection of cyanoacrylate glue.I had an allergic reaction to the glue.Since (b)(6) 2022 to present ((b)(6) 2022) i have had 2 minor surgeries, 2 major surgeries, and two hospitalizations.All lab data from the above mentioned procedures will be made available upon request.Fda safety report id# (b)(4).

• Brand Name: VENASEAL
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 14934579
• MDR Text Key: 295429054
• Report Number: MW5110685
• 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: 06/30/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2022
• Patient Sequence Number: 1
• Treatment: CALCIUM TABLETS; DUPIXENT FOR ASTHMA; SINGULAIR FOR ALLERGIES ; VITAMIN D
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White