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 |