MERIT CUSTOM KIT K09-MST2294A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-09-20 for MERIT CUSTOM KIT K09-MST2294A manufactured by Merit Medical Systems, Inc..

MAUDE Entry Details

Report Number1721504-2019-00069
MDR Report Key9098764
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-09-20
Date of Report2019-08-09
Date of Event2019-07-23
Date Mfgr Received2019-09-13
Device Manufacturer Date2018-12-07
Date Added to Maude2019-09-20
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 W MERIT PARKWAY
Manufacturer CitySOUTH JORDAN 84095
Manufacturer CountryUS
Manufacturer Postal84095
Manufacturer Phone8012081600
Manufacturer G1MERIT MEDICAL SYSTEMS, INC.
Manufacturer Street1600 W MERIT PARKWAY
Manufacturer CitySOUTH JORDAN 84095
Manufacturer CountryUS
Manufacturer Postal Code84095
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMERIT CUSTOM KIT
Generic NameCUSTOM KIT
Product CodeOEZ
Date Received2019-09-20
Returned To Mfg2019-09-09
Catalog NumberK09-MST2294A
Lot NumberH1479449
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMERIT MEDICAL SYSTEMS, INC.
Manufacturer Address1600 W MERIT PARKWAY SOUTH JORDAN 84095 US 84095


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.