BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENASEAL

    MDR report key: 15834332 · Received November 18, 2022

    Report

    Report Number
    MW5113376
    Event Type
    Injury
    Date Received
    November 18, 2022
    Date of Event
    October 10, 2022
    Report Date
    November 16, 2022
    Manufacturer
    MEDTRONIC INC.
    Product Code
    PJQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON OCTOBER 11TH AND 12TH, I HAD THE VENASEAL PROCEDURE TO REROUTE BLOOD TO HEALTHY VEINS. A FEW DAYS AFTERWARDS MY LEGS BECAME ITCHY, RED, PAINFUL, AND EXTREMELY SWOLLEN. I ALSO DEVELOPED RASH ON BODY, ARMS, LEGS, BUTTOCK THAT WERE ITCHY. I WAS STARTED ON A MEDROL DOSE PACK BUT AFTER A FEW DAYS, I DIDN'T NOTICE ANY IMPROVEMENT. I DEBATED GOING TO THE EMERGENCY ROOM AND REGRET THAT I DID NOT GO BUT INSTEAD I CALLED THE SURGEON AGAIN, AND I WAS SWITCHED TO HIGH DOSE OF PREDNISONE TAPER AND PRESCRIBED SOME CREAM THAT HAD TO COMPOUNDED AT A SPECIALTY PHARMACY THAT WAS EXPENSIVE. THE CREAMED BURNED BUT IT WAS ALMOST A WELCOMED CHANGE BECAUSE IT WAS NOT ITCHY. I FINALLY FINISHED THE PREDNISONE TAPER BUT I STILL HAVE ITCHINESS, DISCOLORATION ON MY LEGS, PAIN IN MY LEGS, A FEELING OF HEAVINESS IN MY LEGS WHEN I WALK, AND MY SKIN LOOKS LIKE IT IS PEELING IN SOME AREAS. I ALSO DEVELOPED SHORTNESS OF BREATH AND NOW HAVE TO TAKE A RESCUE INHALER. IT HAS BEEN A HORRIBLE EXPERIENCE. THE NOT KNOWING OF WHEN I WILL BE SYMPTOM FREE FROM THE VENASEAL PROCEDURE IS WORRISOME. PLEASE FEEL FREE TO REACH OUT FOR ANY ADDITIONAL INFORMATION YOU MAY NEED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371386 VENASEAL AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Other| S| R BENADRYL | EFFEXOR | IBUPROFEN | PEPCID| ZYRTEC