HEMASHIELD PLATINIUM WOVEN DOUBLE VELOUR M00202175430P0

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 2019-09-19 for HEMASHIELD PLATINIUM WOVEN DOUBLE VELOUR M00202175430P0 manufactured by Intervascular Sas.

MAUDE Entry Details

Report Number1640201-2019-00047
MDR Report Key9087559
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-09-19
Date of Report2019-11-07
Date of Event2019-08-22
Date Mfgr Received2019-10-11
Device Manufacturer Date2019-04-24
Date Added to Maude2019-09-19
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
Generic NameGRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
Product CodeMAL
Date Received2019-09-19
Model NumberM00202175430P0
Catalog NumberM00202175430P0
Lot Number19D24
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerINTERVASCULAR SAS
Manufacturer AddressZONE INDUSTRIELLE ATHELIA I LA CIOTAT US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-09-19

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