VASCURE FOR VASCULAR REPAIR CMCV-013-609

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-13 for VASCURE FOR VASCULAR REPAIR CMCV-013-609 manufactured by Aziyo Biologics, Inc..

MAUDE Entry Details

Report Number3005619880-2019-00011
MDR Report Key9315072
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-13
Date of Report2019-11-12
Date of Event2019-09-14
Device Manufacturer Date2019-05-07
Date Added to Maude2019-11-13
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 ContactMR. ANDREW GREEN
Manufacturer Street1100 OLD ELLIS ROAD STE 1200
Manufacturer CityROSWELL GA 30076
Manufacturer CountryUS
Manufacturer Postal30076
Manufacturer G1AZIYO BIOLOGICS, INC.
Manufacturer Street1100 OLD ELLIS ROAD STE 1200
Manufacturer CityROSWELL GA 30076
Manufacturer CountryUS
Manufacturer Postal Code30076
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVASCURE FOR VASCULAR REPAIR
Generic NameVASCURE FOR VASCULAR REPAIR
Product CodeDXZ
Date Received2019-11-13
Model NumberCMCV-013-609
Lot NumberM19E1184
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAZIYO BIOLOGICS, INC.
Manufacturer Address1100 OLD ELLIS ROAD STE 1200 ROSWELL GA 30076 US 30076


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-13

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