HERC III 360 T401160 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,foreig report with the FDA on 2019-09-27 for HERC III 360 T401160 N/A manufactured by Terumo Cardiovascular Systems Corporation.

MAUDE Entry Details

Report Number1124841-2019-00266
MDR Report Key9128591
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-09-27
Date of Report2019-10-21
Date of Event2019-08-30
Date Mfgr Received2019-10-04
Date Added to Maude2019-09-27
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. 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 NameHERC III 360
Generic NameHERCULES ARM
Product CodeMWS
Date Received2019-09-27
Returned To Mfg2019-10-04
Model NumberT401160
Catalog NumberN/A
Lot NumberT00553
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
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 2019-09-27

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