LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER e1651-84 E1651-84

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 2020-03-11 for LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER e1651-84 E1651-84 manufactured by Lemaitre Vascular, Inc..

MAUDE Entry Details

Report Number1220948-2020-00027
MDR Report Key9817816
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-11
Date of Report2020-03-10
Date Mfgr Received2020-02-11
Date Added to Maude2020-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. PRAGYA THIKEY
Manufacturer Street63 SECOND AVE
Manufacturer CityBURLINGTON, MA
Manufacturer CountryUS
Manufacturer Phone2212266152
Manufacturer G1LEMAITRE VASCULAR, INC.
Manufacturer Street63 SECOND AVE
Manufacturer CityBURLINGTON, MA
Manufacturer CountryUS
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER
Generic NameEMBOLECTOMY CATHETER
Product CodeDXE
Date Received2020-03-11
Model Numbere1651-84
Catalog NumberE1651-84
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLEMAITRE VASCULAR, INC.
Manufacturer Address63 SECOND AVE BURLINGTON, MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-11

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