ARGON ARTERIAL NEEDLE 195318

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-20 for ARGON ARTERIAL NEEDLE 195318 manufactured by Argon Medical Devices Inc..

MAUDE Entry Details

Report Number8716075
MDR Report Key8716075
Date Received2019-06-20
Date of Report2019-04-23
Date of Event2019-04-09
Report Date2019-04-23
Date Reported to FDA2019-04-23
Date Reported to Mfgr2019-06-20
Date Added to Maude2019-06-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARGON ARTERIAL NEEDLE
Generic NameGUIDE, NEEDLE, SURGICAL
Product CodeGDF
Date Received2019-06-20
Catalog Number195318
Lot Number11243540
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age0 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerARGON MEDICAL DEVICES INC.
Manufacturer Address1445 FLAT CREEK RD ATHENS TX 75751 US 75751


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-20

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