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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC VENASEAL; AGENT, OCCLUDING, VASCULAR, PERMANENT
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MEDTRONIC VENASEAL; AGENT, OCCLUDING, VASCULAR, PERMANENT Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Skin Discoloration (2074); Swelling (2091); Burning Sensation (2146); Tingling (2171); Numbness (2415); Alteration In Body Temperature (2682)
Event Date 09/12/2016
Event Type  Injury  
Event Description
I had the venaseal procedure done, immediately following the procedure while still on the table my legs got red, hot, swollen and began to burn.I was told that this is normal.My symptoms began to worsen and 2 days after the procedure, the dr called to tell me that i was having an allergic reaction to the venaseal product.I was put on steroids and while on the steroids i had another allergic reaction to the product where my face swelled and i developed hives over my entire body.I was told at this time that other people have had allergic reactions to the venaseal product.I was on steroids for 7 weeks.Now that i am off the steroids for over a year i still have burning, itching, numbness, tingling and swelling in my legs and now my feet.I have darkening of my skin where the product was injected and i have now been diagnosed with reflex sympathetic dystrophy (crps) in my legs and feet.
 
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Brand Name
VENASEAL
Type of Device
AGENT, OCCLUDING, VASCULAR, PERMANENT
Manufacturer (Section D)
MEDTRONIC
MDR Report Key7156972
MDR Text Key96234460
Report NumberMW5074325
Device Sequence Number1
Product Code PJQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Weight58
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