PRESSURE MONITORING KIT VO0144TTPL

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 2020-02-05 for PRESSURE MONITORING KIT VO0144TTPL manufactured by Edwards Lifesciences Dr.

MAUDE Entry Details

Report Number2015691-2020-10388
MDR Report Key9671555
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-05
Date of Report2020-01-17
Date of Event2020-01-16
Date Mfgr Received2020-01-17
Date Added to Maude2020-02-05
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 ContactMRS SAMANTHA EVELEIGH
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492503939
Manufacturer G1EDWARDS LIFESCIENCES DR
Manufacturer StreetPARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5
Manufacturer CityHAINA, SAN CRISTOBAL
Manufacturer CountryDR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRESSURE MONITORING KIT
Generic NameTRANSDUCER, PRESSURE, CATHETER TIP
Product CodeDXO
Date Received2020-02-05
Returned To Mfg2020-02-11
Model NumberVO0144TTPL
Lot NumberLE0827MT
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES DR
Manufacturer AddressPARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 HAINA, SAN CRISTOBAL DR


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-05

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