NS FX25REC W/RES 3ZZ*FX25RECA N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-02 for NS FX25REC W/RES 3ZZ*FX25RECA N/A manufactured by Terumo Cardiovascular Systems Corporation.

MAUDE Entry Details

Report Number1124841-2020-00054
MDR Report Key9777135
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-02
Date of Report2020-03-02
Date of Event2020-02-13
Date Mfgr Received2020-02-14
Date Added to Maude2020-03-02
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. CATHLEEN HARGREAVES
Manufacturer Street125 BLUE BALL ROAD
Manufacturer CityELKTON MD 21921
Manufacturer CountryUS
Manufacturer Postal21921
Manufacturer Phone8002837866
Manufacturer G1SAME
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNS FX25REC W/RES
Generic NameBLOOD GAS OXYGENATOR
Product CodeDTZ
Date Received2020-03-02
Returned To Mfg2020-02-18
Model Number3ZZ*FX25RECA
Catalog NumberN/A
Lot NumberXM21
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Manufacturer Address125 BLUE BALL ROAD ELKTON MD 21921 US 21921


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-02

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