ACIST CVI 014657

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-06 for ACIST CVI 014657 manufactured by Acist Medical Systems, Inc..

MAUDE Entry Details

Report Number2134243-2020-00003
MDR Report Key9802612
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-06
Date of Report2020-02-05
Date of Event2020-02-04
Date Mfgr Received2020-02-05
Device Manufacturer Date2019-12-20
Date Added to Maude2020-03-06
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
Manufacturer CountryUS
Manufacturer Phone9959347
Manufacturer G1ACIST MEDICAL SYSTEMS, INC.
Manufacturer Street7905 FULLER ROAD
Manufacturer CityEDEN PRAIRIE, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACIST
Generic NameINJECTOR AND SYRINGE, ANGIOGRAPHIC
Product CodeDXT
Date Received2020-03-06
Returned To Mfg2020-02-11
Model NumberCVI
Catalog Number014657
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerACIST MEDICAL SYSTEMS, INC.
Manufacturer Address7905 FULLER ROAD EDEN PRAIRIE, MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention 2020-03-06

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