HEMASHIELD PLATINIUM WOVEN DOUBLE VELOUR VASCULAR GRAFT M00202175826P0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-03 for HEMASHIELD PLATINIUM WOVEN DOUBLE VELOUR VASCULAR GRAFT M00202175826P0 manufactured by Intervascular Sas.

MAUDE Entry Details

Report Number1640201-2020-00002
MDR Report Key9660850
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-02-03
Date of Report2020-02-03
Date of Event2020-01-02
Date Mfgr Received2020-01-05
Device Manufacturer Date2018-08-01
Date Added to Maude2020-02-03
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 ContactMS. FRANCOISE GAUDUCHON
Manufacturer StreetZONE INDUSTRIELLE ATHELIA I
Manufacturer CityLA CIOTAT
Manufacturer CountryUS
Manufacturer G1INTERVASCULAR SAS
Manufacturer StreetZONE INDUSTRIELLE ATHELIA I
Manufacturer CityLA CIOTAT
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEMASHIELD PLATINIUM WOVEN DOUBLE VELOUR VASCULAR GRAFT
Generic NameGRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
Product CodeMAL
Date Received2020-02-03
Returned To Mfg2020-01-16
Model NumberM00202175826P0
Catalog NumberM00202175826P0
Lot Number18H01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTERVASCULAR SAS
Manufacturer AddressZONE INDUSTRIELLE ATHELIA I LA CIOTAT US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-03

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