MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET MPIS-401-10.0-SC-NT-SST

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 2020-03-24 for MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET MPIS-401-10.0-SC-NT-SST manufactured by Cook Inc.

MAUDE Entry Details

Report Number1820334-2020-00674
MDR Report Key9873775
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-24
Date of Report2020-03-24
Date Mfgr Received2020-03-25
Date Added to Maude2020-03-24
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. JENNIFER CANADA
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8128294891
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
Generic NameDYB INTRODUCER, CATHETER
Product CodeDYB
Date Received2020-03-24
Catalog NumberMPIS-401-10.0-SC-NT-SST
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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