TERUMO CARDIOVASCULAR PROCEDURE KIT 76735

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-16 for TERUMO CARDIOVASCULAR PROCEDURE KIT 76735 manufactured by Terumo Cardiovascular Systems Corporation.

MAUDE Entry Details

Report Number1212122-2019-00008
MDR Report Key9072037
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-09-16
Date of Report2019-09-16
Date of Event2019-08-21
Date Mfgr Received2019-08-23
Device Manufacturer Date2019-07-09
Date Added to Maude2019-09-16
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. KIM MEJIA
Manufacturer Street28 HOWE STREET
Manufacturer CityASHLAND MA 01721
Manufacturer CountryUS
Manufacturer Postal01721
Manufacturer Phone5082312454
Manufacturer G1SAME
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTERUMO CARDIOVASCULAR PROCEDURE KIT
Generic NameCARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK
Product CodeOEZ
Date Received2019-09-16
Returned To Mfg2019-09-10
Model Number76735
Lot NumberX28901264
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Manufacturer Address28 HOWE STREET ASHLAND MA 01721 US 01721


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-16

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