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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT
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MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932)
Event Date 11/01/2018
Event Type  Injury  
Manufacturer Narrative
Mw5081100.If information is provided in the future, a supplemental report will be issued.
 
Event Description
A patient who was treated with venaseal had several adverse reactions, including hypersensitivity and cellulitis.It was reported that it was the first time the physician used a venaseal kit in a patient and aftercare instructions were not as detailed as expected and follow up was poor after patient complained of adverse reactions.Emergency admission was necessary to treat the adverse reactions.
 
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Brand Name
VENA SEAL CLOSURE SYSTEM
Type of Device
AGENT, OCCLUDING, VASCULAR, PERMANENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8169849
MDR Text Key130514042
Report Number9612164-2018-03654
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 Other
Type of Report Initial
Report Date 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received12/11/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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