MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-03 for ROSCOE RMI-15MINI manufactured by Danyang Xinya Valve Co., Ltd.
| Report Number | 3012316249-2019-00028 |
| MDR Report Key | 9152520 |
| Date Received | 2019-10-03 |
| Date of Report | 2019-10-03 |
| Date Facility Aware | 2019-09-13 |
| Report Date | 2019-10-03 |
| Date Reported to FDA | 2019-10-03 |
| Date Reported to Mfgr | 2019-10-03 |
| Date Added to Maude | 2019-10-03 |
| 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 | ROSCOE |
| Generic Name | REGULATOR 0-15 LPM |
| Product Code | CAN |
| Date Received | 2019-10-03 |
| Model Number | RMI-15MINI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 21 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DANYANG XINYA VALVE CO., LTD |
| Manufacturer Address | NO. 12 DONGJIN WEST ROAD YANLING TOWN DANYANG JIANGSU, CHINA 212341 CH 212341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-10-03 |