MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-28 for ACIST MANIFOLD KIT manufactured by Acist Medical Systems, Inc..
| Report Number | MW5090737 |
| MDR Report Key | 9249833 |
| Date Received | 2019-10-28 |
| Date of Report | 2019-10-25 |
| Date of Event | 2019-10-17 |
| Date Added to Maude | 2019-10-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACIST MANIFOLD KIT |
| Generic Name | INJECTOR AND SYRINGE, ANGIOGRAPHIC |
| Product Code | DXT |
| Date Received | 2019-10-28 |
| Returned To Mfg | 2019-10-25 |
| Lot Number | 18119G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Address | EDEN PRAIRIE MN 55344 US 55344 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-28 |