AFX2 BEA28-100/I20-40

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 2020-03-31 for AFX2 BEA28-100/I20-40 manufactured by Endologix.

MAUDE Entry Details

Report Number2031527-2020-00122
MDR Report Key9908792
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-04
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2016-06-28
Date Added to Maude2020-03-31
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. EMILE PINSONNEAULT
Manufacturer Street3910 BRICKWAY BLVD ,
Manufacturer CitySANTA ROSA CA 95403
Manufacturer CountryUS
Manufacturer Postal95403
Manufacturer Phone8009832284
Manufacturer G1ENDOLOGIX SANTA ROSA
Manufacturer Street3910 BRICKWAY BLVD ,
Manufacturer CitySANTA ROSA CA 95403
Manufacturer CountryUS
Manufacturer Postal Code95403
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAFX2
Generic NameBIFURCATED STENT GRAFT
Product CodeMIH
Date Received2020-03-31
Model NumberBEA28-100/I20-40
Lot Number1354807-002
Device Expiration Date2017-06-14
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerENDOLOGIX
Manufacturer Address2 MUSICK , IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-31

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