TERUMO CARDIOVASCULAR PROCEDURE KIT B73281-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-27 for TERUMO CARDIOVASCULAR PROCEDURE KIT B73281-01 manufactured by Terumo Cardiovascular Systems Corporation.

MAUDE Entry Details

Report Number1212122-2020-00001
MDR Report Key9888954
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-03-02
Date Mfgr Received2020-03-03
Device Manufacturer Date2019-11-14
Date Added to Maude2020-03-27
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. JEAN BURNS
Manufacturer Street28 HOWE STREET
Manufacturer CityASHLAND MA 01721
Manufacturer CountryUS
Manufacturer Postal01721
Manufacturer Phone5082312417
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 Received2020-03-27
Model NumberB73281-01
Lot NumberX46912690
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Manufacturer Address28 HOWE STREET ASHLAND MA 01721 US 01721


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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