ARTEGRAFT AG840

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-05 for ARTEGRAFT AG840 manufactured by Artegraft, Inc..

MAUDE Entry Details

Report Number2247686-2020-00001
MDR Report Key9793114
Report SourceOTHER
Date Received2020-03-05
Date of Report2020-03-05
Date of Event2019-10-28
Date Mfgr Received2020-02-06
Device Manufacturer Date2019-06-05
Date Added to Maude2020-03-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CYNTHIA SALTER
Manufacturer Street206 NORTH CENTER DRIVE
Manufacturer CityNORTH BRUNSWICK, NJ
Manufacturer CountryUS
Manufacturer Phone4228333
Manufacturer G1ARTEGRAFT, INC.
Manufacturer Street206 NORTH CENTER DRIVE
Manufacturer CityNORTH BRUNSWICK, NJ
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARTEGRAFT
Generic NameCOLLAGEN VASCULAR GRAFT
Product CodeLXA
Date Received2020-03-05
Model NumberAG840
Catalog NumberAG840
Lot Number19D109-047
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARTEGRAFT, INC.
Manufacturer Address206 NORTH CENTER DRIVE NORTH BRUNSWICK, NJ US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-05

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