MEDEX MX390

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-09-25 for MEDEX MX390 manufactured by Smiths Medical Asd, Inc.

MAUDE Entry Details

Report Number3012307300-2019-05499
MDR Report Key9119722
Report SourceUSER FACILITY
Date Received2019-09-25
Date of Report2019-10-28
Date of Event2019-08-25
Date Mfgr Received2019-10-17
Device Manufacturer Date2017-12-04
Date Added to Maude2019-09-25
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 ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer G1SMITHS MEDICAL ASD INC.
Manufacturer Street6250 SHIER RINGS ROAD
Manufacturer CityDUBLIN OH 43016
Manufacturer CountryUS
Manufacturer Postal Code43016
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDEX
Generic NameSYRINGE, BALLOON INFLATION
Product CodeMAV
Date Received2019-09-25
Returned To Mfg2019-09-24
Catalog NumberMX390
Lot Number3533705
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-25

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