EAGLE EYE PLATINUM ST CATHETER 85900PST 400-0200.141

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 2020-02-27 for EAGLE EYE PLATINUM ST CATHETER 85900PST 400-0200.141 manufactured by Philips Volcano.

MAUDE Entry Details

Report Number2939520-2020-00007
MDR Report Key9760430
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-27
Date of Report2019-11-14
Date of Event2019-11-13
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-01-28
Date Added to Maude2020-02-27
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 ContactMS. MELISSA MANGUM
Manufacturer Street2870 KILGORE ROAD
Manufacturer CityRANCHO CORDOVA CA 95670
Manufacturer CountryUS
Manufacturer Postal95670
Manufacturer Phone8584650468
Manufacturer G1VOLCARICA S.R.L.
Manufacturer StreetCOYOL FREE ZONE & BUSINESS PARK B37
Manufacturer CityALAJUELA
Manufacturer CountryCS
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameEAGLE EYE PLATINUM ST CATHETER
Generic NameCATHETER, ULTRASOUND, INTRAVASCULAR
Product CodeOBJ
Date Received2020-02-27
Returned To Mfg2019-12-04
Model Number85900PST
Catalog Number400-0200.141
Lot Number0301718473
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS VOLCANO
Manufacturer Address2870 KILGORE ROAD RANCHO CORDOVA CA 95670 US 95670

Device Sequence Number: 101

Product Code---
Date Received2020-02-27
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-27

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