SMART 120 SHT SHAFT 8X120MM C08100SV

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 2020-03-30 for SMART 120 SHT SHAFT 8X120MM C08100SV manufactured by Cordis Corporation.

MAUDE Entry Details

Report Number9616099-2020-03608
MDR Report Key9899631
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2019-04-16
Date Added to Maude2020-03-30
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 ContactMRS. KARLA CASTRO
Manufacturer Street14201 NW 60TH AVE
Manufacturer CityMIAMI LAKES FL 33014
Manufacturer CountryUS
Manufacturer Postal33014
Manufacturer Phone7863138372
Manufacturer G1CORDIS CORPORATION
Manufacturer Street14201 NW 60TH AVE
Manufacturer CityMIAMI LAKES FL 33014
Manufacturer CountryUS
Manufacturer Postal Code33014
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMART 120 SHT SHAFT 8X120MM
Generic NameCATHETER, BILIARY, DIAGNOSTIC
Product CodeFGE
Date Received2020-03-30
Catalog NumberC08100SV
Lot Number17856334
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCORDIS CORPORATION
Manufacturer Address14201 NW 60TH AVE MIAMI LAKES FL 33014 US 33014


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening 2020-03-30

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