MERIT CUSTOM KIT K12-MZT8201A

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 2019-05-10 for MERIT CUSTOM KIT K12-MZT8201A manufactured by Merit Medical Systems Inc..

Event Text Entries

[144699364] The device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10


[144699365] The distributor alleges a defect in the packaging was found during their initial inspection of received product. The device was not sent to a user facility.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721504-2019-00033
MDR Report Key8599578
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-05-10
Date of Report2019-04-11
Date of Event2019-02-14
Date Mfgr Received2019-05-17
Device Manufacturer Date2018-11-21
Date Added to Maude2019-05-10
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 INC.
Manufacturer Street1600 MERIT PARKWAY
Manufacturer CitySOUTH JORDAN, UT 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 CodeOEQ
Date Received2019-05-10
Returned To Mfg2019-05-13
Catalog NumberK12-MZT8201A
Lot NumberH1463225
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMERIT MEDICAL SYSTEMS INC.
Manufacturer Address1600 MERIT PARKWAY SOUTH JORDAN, UT 84095 US 84095


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-10

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