ENDO ANCHOR SYSTEM - HELI-FX AAA SG-64

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for ENDO ANCHOR SYSTEM - HELI-FX AAA SG-64 manufactured by Medtronic Ireland.

MAUDE Entry Details

Report Number9612164-2020-01370
MDR Report Key9887658
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-02-21
Date Mfgr Received2020-03-03
Device Manufacturer Date2019-10-03
Date Added to Maude2020-03-27
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 ContactALISON SWEENEY
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Manufacturer CountryIE
Manufacturer Phone091708096
Manufacturer G1MEDTRONIC IRELAND
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Manufacturer CountryIE
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENDO ANCHOR SYSTEM - HELI-FX AAA
Generic NameENDOVASCULAR SUTURING SYSTEM
Product CodeOTD
Date Received2020-03-27
Model NumberSG-64
Catalog NumberSG-64
Lot Number0009951823
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC IRELAND
Manufacturer AddressPARKMORE BUSINESS PARK WEST GALWAY IE


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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