LOTUS INTRODUCER SET H749NTR200 LIS-L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for LOTUS INTRODUCER SET H749NTR200 LIS-L manufactured by Creganna Medical Also D.b.a Creganna Tactx Medical.

MAUDE Entry Details

Report Number3004193842-2020-00008
MDR Report Key9903241
Report SourceDISTRIBUTOR
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-28
Date Mfgr Received2020-03-18
Device Manufacturer Date2019-08-30
Date Added to Maude2020-03-31
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. MAKO SUGIMURA
Manufacturer StreetPARKMORE WEST
Manufacturer CityGALWAY, H91 VN2T
Manufacturer CountryEI
Manufacturer PostalH91 VN2T
Manufacturer G1CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL
Manufacturer StreetPARKMORE WEST
Manufacturer CityGALWAY, H91 VN2T
Manufacturer CountryEI
Manufacturer Postal CodeH91 VN2T
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLOTUS INTRODUCER SET
Generic NameINTRODUCER CATHETER
Product CodeDYB
Date Received2020-03-31
Model NumberH749NTR200
Catalog NumberLIS-L
Lot Number0000011151
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL
Manufacturer AddressPARKMORE WEST GALWAY, H91 VN2T EI H91 VN2T


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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