PRESSURE MONITORING: MEDEX TRANSTAR KIDS KITS MX9544

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-08 for PRESSURE MONITORING: MEDEX TRANSTAR KIDS KITS MX9544 manufactured by Smiths Medical Asd, Inc..

MAUDE Entry Details

Report NumberMW5087944
MDR Report Key8772343
Date Received2019-07-08
Date of Report2019-07-03
Date of Event2019-06-27
Date Added to Maude2019-07-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePRESSURE MONITORING: MEDEX TRANSTAR KIDS KITS
Generic NamePROBE, BLOOD-FLOW, EXTRAVASCULAR
Product CodeDPT
Date Received2019-07-08
Returned To Mfg2019-07-03
Model NumberMX9544
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-08

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