SWAN-GANZ BIPOLAR PACING CATHETER AND KIT (FOR SUPERIOR VENA CAVA INSERTION) PEK074F5

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 SWAN-GANZ BIPOLAR PACING CATHETER AND KIT (FOR SUPERIOR VENA CAVA INSERTION) PEK074F5 manufactured by Edwards Lifesciences, Pr.

MAUDE Entry Details

Report Number2015691-2020-10590
MDR Report Key9727989
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-19
Date of Report2020-01-29
Date of Event2020-01-29
Date Mfgr Received2020-01-29
Device Manufacturer Date2019-04-27
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 ContactMS. LYNN THOMAS
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9497564386
Manufacturer G1EDWARDS LIFESCIENCES, PR
Manufacturer StreetSTATE RD INDUS PK 402 KM 1.4
Manufacturer CityANASCO PR 00610
Manufacturer CountryUS
Manufacturer Postal Code00610
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSWAN-GANZ BIPOLAR PACING CATHETER AND KIT (FOR SUPERIOR VENA CAVA INSERTION)
Generic NamePACING CATHETER
Product CodeLDF
Date Received2020-02-19
Returned To Mfg2020-02-13
Model NumberPEK074F5
Lot Number62132718
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES, PR
Manufacturer AddressSTATE RD INDUS PK 402 KM 1.4 ANASCO PR 00610 US 00610


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-19

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