HYDRO LEMAITRE VALVULOTOME 1009-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-16 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..

MAUDE Entry Details

Report Number1220948-2019-00089
MDR Report Key8794452
Date Received2019-07-16
Date of Report2019-07-15
Date of Event2019-05-22
Date Mfgr Received2019-06-17
Device Manufacturer Date2017-12-18
Date Added to Maude2019-07-16
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 NameHYDRO LEMAITRE VALVULOTOME
Generic NameVALVULOTOME
Product CodeMGZ
Date Received2019-07-16
Catalog Number1009-00
Lot NumberELVH1386V
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerLEMAITRE VASCULAR, INC.
Manufacturer Address63 SECOND AVE BURLINGTON MA 01803 US 01803


Patients

Patient NumberTreatmentOutcomeDate
101. Congenital Not Applicablenomaly; 2. Required No Informationntervention 2019-07-16

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