MERIT CUSTOM KIT K10T-05261

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-09-06 for MERIT CUSTOM KIT K10T-05261 manufactured by Merit Medical Richmond.

MAUDE Entry Details

Report Number1125782-2019-00004
MDR Report Key8969806
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-09-06
Date of Report2019-08-13
Date of Event2019-08-13
Date Mfgr Received2019-10-01
Device Manufacturer Date2019-06-14
Date Added to Maude2019-09-06
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 RICHMOND
Manufacturer Street12701 N KINGSTON AVE
Manufacturer CityCHESTER VA 23836
Manufacturer CountryUS
Manufacturer Postal Code23836
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMERIT CUSTOM KIT
Generic NameCUSTOM KIT
Product CodePPD
Date Received2019-09-06
Catalog NumberK10T-05261
Lot NumberT1589394
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMERIT MEDICAL RICHMOND
Manufacturer Address12701 N KINGSTON AVE CHESTER VA 23836 US 23836


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-06

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