ANGIODYNAMICS 45759 45-759

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-26 for ANGIODYNAMICS 45759 45-759 manufactured by Navilyst Medical, Inc..

MAUDE Entry Details

Report Number9375321
MDR Report Key9375321
Date Received2019-11-26
Date of Report2019-11-15
Date of Event2019-11-13
Report Date2019-11-15
Date Reported to FDA2019-11-15
Date Reported to Mfgr2019-11-26
Date Added to Maude2019-11-26
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 OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameANGIODYNAMICS
Generic NameDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
Product CodeDRE
Date Received2019-11-26
Model Number45759
Catalog Number45-759
Lot Number5522907
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age3 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerNAVILYST MEDICAL, INC.
Manufacturer Address26 FOREST STREET MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-26

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