OUTBACK ELITE 80CM RE-ENTRY OTB59080A

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 2019-10-08 for OUTBACK ELITE 80CM RE-ENTRY OTB59080A manufactured by Cordis Corporation.

MAUDE Entry Details

Report Number9616099-2019-03260
MDR Report Key9166990
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-10-08
Date of Report2019-11-18
Date of Event2019-09-05
Date Mfgr Received2019-11-08
Device Manufacturer Date2019-04-05
Date Added to Maude2019-10-08
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 NameOUTBACK ELITE 80CM RE-ENTRY
Generic NameCATHETER FOR CROSSING TOTAL OCCLUSIONS
Product CodePDU
Date Received2019-10-08
Catalog NumberOTB59080A
Lot Number17850680
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCORDIS CORPORATION
Manufacturer Address14201 NW 60TH AVE MIAMI LAKES FL 33014 US 33014


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-10-08

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