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

Patient Problems Erythema (1840); Pain (1994); Burning Sensation (2146); Swelling/ Edema (4577); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/22/2024

Event Type  Injury  

Event Description

I underwent a vein ablation in my left leg for venous insufficiency.Two products were used which resulted in me experiencing side effects: varithena and venaseal.After these products were injected in my leg, i experienced severe pain, burning, redness of the skin, swelling in the calf area as well as a lump on the backside of my calf.When touching my calf, it feels as hard as a rock.Since the procedure, i have experienced no improvement in my symptoms.The procedure was intended to heal ulcers present on my leg, and 3 weeks later there has been no improvement.Both products appear to be ineffective.

• Brand Name: VENASEAL
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 18922391
• MDR Text Key: 338110795
• Report Number: MW5152926
• 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: 03/14/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2024
• Patient Sequence Number: 1
• Treatment: METOPROLOL. ; TARTRATE.; VARITHENA.
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: White