MERIT PRESSURE MONITORING KIT K11-00096

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-23 for MERIT PRESSURE MONITORING KIT K11-00096 manufactured by Merit Medical Systems, Inc.

MAUDE Entry Details

Report NumberMW5089985
MDR Report Key9106570
Date Received2019-09-23
Date of Report2019-09-18
Date of Event2019-09-16
Date Added to Maude2019-09-23
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 NameMERIT PRESSURE MONITORING KIT
Generic NameCARDIOVASCULAR PROCEDURE KIT
Product CodeOEZ
Date Received2019-09-23
Model NumberK11-00096
Lot NumberH1491069
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMERIT MEDICAL SYSTEMS, INC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-23

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