ACIST CVI 014657

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-20 for ACIST CVI 014657 manufactured by Acist Medical Systems, Inc..

MAUDE Entry Details

Report Number2134243-2019-00020
MDR Report Key9350368
Date Received2019-11-20
Date of Report2019-10-23
Date of Event2019-10-22
Date Mfgr Received2019-10-23
Device Manufacturer Date2015-03-27
Date Added to Maude2019-11-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactJEFF AUDRITSH
Manufacturer Street7905 FULLER ROAD
Manufacturer CityEDEN PRAIRIE MN 55344
Manufacturer CountryUS
Manufacturer Postal55344
Manufacturer Phone9529959347
Manufacturer G1ACIST MEDICAL SYSTEMS, INC.
Manufacturer Street7905 FULLER ROAD
Manufacturer CityEDEN PRAIRIE MN 55344
Manufacturer CountryUS
Manufacturer Postal Code55344
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameACIST
Generic NameINJECTOR AND SYRINGE, ANGIOGRAPHIC
Product CodeDXT
Date Received2019-11-20
Model NumberCVI
Catalog Number014657
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerACIST MEDICAL SYSTEMS, INC.
Manufacturer Address7905 FULLER ROAD EDEN PRAIRIE MN 55344 US 55344


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention 2019-11-20

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