PROWLER SELECT LPES 45 DEG TIP 606-S155FX 606S155FX

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 2020-02-19 for PROWLER SELECT LPES 45 DEG TIP 606-S155FX 606S155FX manufactured by Codman And Shurtleff, Inc.

MAUDE Entry Details

Report Number1226348-2020-00006
MDR Report Key9728187
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-19
Date of Report2020-01-28
Date of Event2020-01-28
Date Mfgr Received2020-03-10
Date Added to Maude2020-02-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. GABRIEL ALFAGEME
Manufacturer Street31 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone949789-868
Manufacturer G1CODMAN & SHURTLEFF, INC. (JUAREZ)
Manufacturer StreetCIRCUITO INTERIOR NORTE #1820 PARQUE INDUSTRIAL SALVARCAR
Manufacturer CityJUAREZ CHIHUAHUA 32574
Manufacturer CountryMX
Manufacturer Postal Code32574
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROWLER SELECT LPES 45 DEG TIP
Generic NameCATHETER, CONTINUOUS FLUSH
Product CodeKRA
Date Received2020-02-19
Returned To Mfg2020-03-10
Model Number606-S155FX
Catalog Number606S155FX
Lot Number30140219
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCODMAN AND SHURTLEFF, INC
Manufacturer Address325 PARAMOUNT DR RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-19

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