MAUDE Adverse Event Report: UNKNOWN VENASEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033)

Event Date 01/18/2023

Event Type  Injury  

Event Description

I had a procedure done called endovenous abalation of the right greater saphenous vein with venaseal closure system.By february i was experiencing a redness on my lower thigh with a red pencil line running along the vein where the glue was inserted to the hole just above my ankle where they entered the vein.Bumps began to appear one at a time running up my leg following that vein.They became raised, inflamed and very tender.I have spent time in the hospital trying to get help.I have gone to an infectious disease center where they discovered it was an reaction and not an infection.There is no fix! hopefully over time my body will ignore the glue and the bumps will heal.This experience has totally changed my life style.I want others to know this is a possible reaction to this procedure before making their decision.

• Brand Name: VENASEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17836873
• MDR Text Key: 324657729
• Report Number: MW5146275
• 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: 09/21/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2023
• Patient Sequence Number: 1
• Treatment: CALCIUM.; CARBIDOPA/LEVODOPA.; CLONAZEPAM.; HAIR, SKIN AND NAILS COLLAGEN SUPPORT.; I WEAR BRACES ON BOTH LEGS.; INFUSION OF IG'S EVERY 4 WEEKS.; LATANOPROST.; METOPROLOL.; MULTIVITAMIN.; SYNTHROID.; VITAMIN A.; VITAMIN D3.
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White