VENA SEAL CLOSURE SYSTEM VS-402

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-26 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.

Event Text Entries

[172803667] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[172803668] Patient successfully treated with venaseal with favorable outcome. 3 weeks later patient returned for second venaseal treatment of great saphenous vein (gsv). 12 days post second venaseal treatment, the patient returned complaining of a full body rash. The patient was given medrol and the symptoms are reported to have cleared up. No additional treatment required.
Patient Sequence No: 1, Text Type: D, B5


[188148544] Aware date should be 13 mar 2020. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188148545] Patient successfully treated with venaseal with favorable outcome. 3 weeks later patient returned for second venaseal treatment of great saphenous vein (gsv). 12 days post second venaseal treatment, the patient returned complaining of a full body rash. The patient was given medrol and the symptoms are reported to have cleared up. No additional treatment required. No further injury reported.
Patient Sequence No: 1, Text Type: D, B5


[188148546] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612164-2019-05298
MDR Report Key9519342
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-12-26
Date of Report2020-03-18
Date of Event2019-12-09
Date Mfgr Received2020-03-13
Date Added to Maude2019-12-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTONI O'DOHERTY
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Manufacturer Phone091708734
Manufacturer G1MEDTRONIC IRELAND
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVENA SEAL CLOSURE SYSTEM
Generic NameAGENT, OCCLUDING, VASCULAR, PERMANENT
Product CodePJQ
Date Received2019-12-26
Catalog NumberVS-402
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC IRELAND
Manufacturer AddressPARKMORE BUSINESS PARK WEST GALWAY


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-12-26

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