HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR M00202175926P0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-09 for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR M00202175926P0 manufactured by Intervascular Sas.

MAUDE Entry Details

Report Number2242352-2019-01110
MDR Report Key9173731
Date Received2019-10-09
Date of Report2019-10-09
Date of Event2019-08-31
Date Facility Aware2019-09-09
Report Date2019-10-09
Date Reported to FDA2019-10-09
Date Reported to Mfgr2019-10-09
Date Added to Maude2019-10-09
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEMASHIELD PLATINUM WOVEN DOUBLE VELOUR
Generic NameGRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
Product CodeMAL
Date Received2019-10-09
Model NumberM00202175926P0
Catalog NumberM00202175926P0
Lot Number18L07
Device AvailabilityN
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTERVASCULAR SAS
Manufacturer AddressZONE INDUSTRIELLE ATHELIA I LA CIOTAT US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-09

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