TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP 7210386F

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-20 for TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP 7210386F manufactured by Lemaitre Vascular, Inc..

MAUDE Entry Details

Report Number1220948-2018-00131
MDR Report Key9099881
Date Received2019-09-20
Date of Report2019-08-22
Date of Event2019-09-20
Date Mfgr Received2019-08-22
Date Added to Maude2019-09-20
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 ContactMR. PRAGYA THIKEY
Manufacturer Street63 SECOND AVE
Manufacturer CityBURLINGTON MA 01803
Manufacturer CountryUS
Manufacturer Postal01803
Manufacturer Phone7812212266
Manufacturer G1LEMAITRE VASCULAR, INC.
Manufacturer Street63 SECOND AVE
Manufacturer CityBURLINGTON MA 01803
Manufacturer CountryUS
Manufacturer Postal Code01803
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP
Generic NameVASICOSE VEIN ABLATION SYSTEM
Product CodeDWQ
Date Received2019-09-20
Catalog Number7210386F
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLEMAITRE VASCULAR, INC.
Manufacturer Address63 SECOND AVE BURLINGTON MA 02148 US 02148


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-20

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