MERIT MAK MINI ACCESS KIT MICRO-PUNCTURE WIRE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-08 for MERIT MAK MINI ACCESS KIT MICRO-PUNCTURE WIRE manufactured by Merit Medical System, Inc..

MAUDE Entry Details

Report NumberMW5090995
MDR Report Key9310587
Date Received2019-11-08
Date of Report2019-11-05
Date of Event2019-10-24
Date Added to Maude2019-11-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
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 MAK MINI ACCESS KIT MICRO-PUNCTURE WIRE
Generic NameDILLATOR VESSEL FOR PERCUTANEOUS, CATHETERIZATION
Product CodeDRE
Date Received2019-11-08
Lot NumberI1609263
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMERIT MEDICAL SYSTEM, INC.
Manufacturer AddressSOUTH JORDAN UT US


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-08

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