TRAPEASE W/CSI INTRO KIT 55CM 466P306A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-11-29 for TRAPEASE W/CSI INTRO KIT 55CM 466P306A manufactured by Cordis Cashel.

MAUDE Entry Details

Report Number1016427-2019-03611
MDR Report Key9391848
Report SourceOTHER
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-07
Date Mfgr Received2019-11-05
Date Added to Maude2019-11-29
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 ContactMRS. KARLA CASTRO
Manufacturer Street14201 NW 60TH AVE
Manufacturer CityMIAMI LAKES FL 33014
Manufacturer CountryUS
Manufacturer Postal33014
Manufacturer Phone7863138372
Manufacturer G1CORDIS CASHEL
Manufacturer StreetCAHIR ROAD CASHEL, CO. TIPPERARY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRAPEASE W/CSI INTRO KIT 55CM
Generic NameFILTER, INTRAVASCULAR, CARDIOVASCULAR
Product CodeDTK
Date Received2019-11-29
Catalog Number466P306A
Lot NumberR0802939
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCORDIS CASHEL
Manufacturer AddressCAHIR ROAD CASHEL, CO. TIPPERARY EI


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2019-11-29

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