MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-10 for ASPIRE CRISTALLE FDR MS-3500 N/A manufactured by Fujifilm Corporation.
| Report Number | 1000513161-2019-00005 |
| MDR Report Key | 8776037 |
| Date Received | 2019-07-10 |
| Date of Report | 2019-07-10 |
| Date of Event | 2019-06-17 |
| Date Facility Aware | 2019-06-17 |
| Report Date | 2019-07-10 |
| Date Reported to Mfgr | 2019-07-10 |
| Date Added to Maude | 2019-07-10 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Brand Name | ASPIRE CRISTALLE |
| Generic Name | DIGITAL BREAST TOMOSYNTHESIS MAMMOGRAPHY SYSTEM |
| Product Code | OTE |
| Date Received | 2019-07-10 |
| Model Number | FDR MS-3500 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FUJIFILM CORPORATION |
| Manufacturer Address | 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN KANAGAWA, 002588538 JA 002588538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-10 |