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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Erythema (1840); Itching Sensation (1943); Rash (2033)

Event Date 11/02/2022

Event Type  Injury  

Event Description

Four (4) days post op from a bilateral venaseal procedure, i experienced intense redness on my thighs and lower leg to my ankle.The physician prescribed a medrol pack, 800 ibuprofen plus 25mg benadryl every 6 hours.That helped for one day.On day 8, i woke up at 330am with a systemic rash from my neck, chest, stomach, both legs and my right ankle was swollen so bad, i could not see the bone.My breathing was becoming labored and we went directly to the emergency room at (b)(6) hospital.The emergency room physician started an iv, they gave me a zyrtec and pushed 3cc's of pepcid, the redness and itchiness began to lessen almost immediately.They pushed a couple cc's of epi and i stayed in the emergency room for the next 4 hours for observation.They recommended a second medrol pack and maintain 1 x zyrtec + 1 pepcid twice a day.I was symptom free for 5 days (now approx.15 days post op).The day of my last medrol pill, the redness came back on my right ankle and also left inner knee/thigh.I used a steroid cream and ice packs on the red areas and that seemed to calm the outbreak.I am now 22 days post op and have finally been symptom free for 3 days and counting, staying on the zyrtec + pepcid regimen and planning on continuing for 60 days to allow for wound healing, capsulation and scaring to occur around the glue.Fda safety report id# (b)(4).

• Brand Name: VENASEAL
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 15806725
• MDR Text Key: 303928924
• Report Number: MW5113303
• 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: 11/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: PEPCID DAILY; ZYRTEC
• Patient Outcome(s): Hospitalization; Other; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American, White, American Indian Or Alaskan Native