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..
| Report Number | 2134243-2020-00003 |
| MDR Report Key | 9802612 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2019-12-20 |
| Date Added to Maude | 2020-03-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEFF AUDRITSH |
| Manufacturer Street | 7905 FULLER ROAD |
| Manufacturer City | EDEN PRAIRIE, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 9959347 |
| Manufacturer G1 | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 7905 FULLER ROAD |
| Manufacturer City | EDEN PRAIRIE, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACIST |
| Generic Name | INJECTOR AND SYRINGE, ANGIOGRAPHIC |
| Product Code | DXT |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-02-11 |
| Model Number | CVI |
| Catalog Number | 014657 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 7905 FULLER ROAD EDEN PRAIRIE, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-06 |