HEMASHIELD PLATINIUM WOVN DOUBLE VELOUR M00202175208P0

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 2019-11-08 for HEMASHIELD PLATINIUM WOVN DOUBLE VELOUR M00202175208P0 manufactured by Intervascular Sas.

MAUDE Entry Details

Report Number1640201-2019-00082
MDR Report Key9294936
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-11-08
Date of Report2019-11-07
Date of Event2019-10-07
Date Mfgr Received2019-10-11
Device Manufacturer Date2019-08-28
Date Added to Maude2019-11-08
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 WOVN DOUBLE VELOUR
Generic NameGRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
Product CodeMAL
Date Received2019-11-08
Returned To Mfg2019-10-23
Model NumberM00202175208P0
Catalog NumberM00202175208P0
Lot Number19H28
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 2019-11-08

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