NAMIC 70055003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-07 for NAMIC 70055003 manufactured by Navilyst Medical, Inc..

MAUDE Entry Details

Report Number9289671
MDR Report Key9289671
Date Received2019-11-07
Date of Report2019-10-11
Date of Event2019-07-18
Report Date2019-10-11
Date Reported to FDA2019-10-11
Date Reported to Mfgr2019-11-07
Date Added to Maude2019-11-07
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
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 NameNAMIC
Generic NameADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
Product CodeDTL
Date Received2019-11-07
Returned To Mfg2019-10-11
Catalog Number70055003
Lot Number5425318
Device AvailabilityR
Device Age2 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerNAVILYST MEDICAL, INC.
Manufacturer Address10 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US 12801


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-07

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