MAK-NV INTRODUCER SYSTEM MAK-NV-004/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-03 for MAK-NV INTRODUCER SYSTEM MAK-NV-004/A manufactured by Merit Medical Systems.

MAUDE Entry Details

Report Number3011642792-2019-00012
MDR Report Key8761006
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-03
Date of Report2019-06-14
Date of Event2019-06-13
Date Mfgr Received2019-08-09
Device Manufacturer Date2018-12-12
Date Added to Maude2019-07-03
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. KATIE SWENSON CQE,CBA,CQPA.
Manufacturer Street1600 MERIT PARKWAY
Manufacturer CitySOUTH JORDAN UT 84095
Manufacturer CountryUS
Manufacturer Postal84095
Manufacturer Phone8012531600
Manufacturer G1MERIT MEDICAL SYSTEMS
Manufacturer Street8830 SIEMPRE VIVA RD #100
Manufacturer CitySAN DIEGO, CA 92154
Manufacturer CountryUS
Manufacturer Postal Code92154
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAK-NV INTRODUCER SYSTEM
Generic NameINTRODUCER SYSTEM
Product CodeGCB
Date Received2019-07-03
Returned To Mfg2019-07-03
Catalog NumberMAK-NV-004/A
Lot NumberI1477671
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMERIT MEDICAL SYSTEMS
Manufacturer Address8830 SIEMPRE VIVA RD #100 SAN DIEGO, CA 92154 US 92154


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-03

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