EMBOSHIELD NAV 6 22438-19

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 EMBOSHIELD NAV 6 22438-19 manufactured by Abbott Vascular.

MAUDE Entry Details

Report Number2024168-2020-03168
MDR Report Key9908164
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-12-20
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 ContactMS. LINDSEY BELL
Manufacturer Street26531 YNEZ RD.
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, REG # 2024168
Manufacturer Street26531 YNEZ ROAD
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal Code925914628
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEMBOSHIELD NAV 6
Generic NameEMBOLIC PROTECTION SYSTEM
Product CodeNTE
Date Received2020-03-31
Model Number22438-19
Catalog Number22438-19
Lot Number9122061
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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