HEMASHIELD HEMASHIELD BIFUCARTED UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-02-24 for HEMASHIELD HEMASHIELD BIFUCARTED UNK manufactured by Intervascular Sas.

MAUDE Entry Details

Report Number1640201-2020-00005
MDR Report Key9743847
Report SourceLITERATURE
Date Received2020-02-24
Date of Report2020-01-27
Date of Event2019-10-14
Date Mfgr Received2020-01-27
Date Added to Maude2020-02-24
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 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
Generic NameGRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
Product CodeMAL
Date Received2020-02-24
Model NumberHEMASHIELD BIFUCARTED
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-02-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.