VICI 26930

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for VICI 26930 manufactured by Veniti, Inc..

MAUDE Entry Details

Report Number2134265-2019-06503
MDR Report Key8692395
Date Received2019-06-12
Date of Report2019-06-12
Date of Event2019-05-20
Date Mfgr Received2019-05-20
Device Manufacturer Date2018-11-14
Date Added to Maude2019-06-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactSONALI ARANGIL
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone6515827403
Manufacturer G1VENITI, INC.
Manufacturer Street4025 CLIPPER COURT
Manufacturer CityFREMONT CA 94538
Manufacturer CountryUS
Manufacturer Postal Code94538
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVICI
Product CodeQAN
Date Received2019-06-12
Model Number26930
Catalog Number26930
Lot Number0018100010
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVENITI, INC.
Manufacturer Address4025 CLIPPER COURT FREMONT CA 94538 US 94538


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-06-12

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