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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT
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COVIDIEN VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT Back to Search Results
Model Number VS-402
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 02/14/2017
Event Type  Injury  
Event Description
Physician used venaseal device to perform a successful vein closure of the great saphenous vein (gsv) on (b)(6) 2017.It was reported that patient complained of painful skin irritation in the area where the treatment took place during the follow-up visit.Patient was prescribed nonsteroidal anti-inflammatory drugs (nsaids).No further information is available on patient's condition.
 
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Brand Name
VENA SEAL CLOSURE SYSTEM
Type of Device
AGENT, OCCLUDING, VASCULAR, PERMANENT
Manufacturer (Section D)
COVIDIEN
951 aviation parkway
morrisville NC 27560
Manufacturer (Section G)
COVIDIEN
951 aviation parkway
morrisville NC 27560
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6398451
MDR Text Key69733508
Report Number3011410703-2017-00047
Device Sequence Number1
Product Code PJQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 02/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberVS-402
Device Catalogue NumberVS-402
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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