MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-09 for ROSCOE ROS-KSB manufactured by Taicang Jingquan Metal Products Co., Ltd.
| Report Number | 3012316249-2019-00032 |
| MDR Report Key | 9171865 |
| Date Received | 2019-10-09 |
| Date of Report | 2019-10-09 |
| Date Facility Aware | 2019-09-20 |
| Report Date | 2019-10-09 |
| Date Reported to FDA | 2019-10-09 |
| Date Reported to Mfgr | 2019-10-09 |
| Date Added to Maude | 2019-10-09 |
| 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 | KNEE SCOOTER |
| Product Code | ITJ |
| Date Received | 2019-10-09 |
| Model Number | ROS-KSB |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 53 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TAICANG JINGQUAN METAL PRODUCTS CO., LTD |
| Manufacturer Address | NO. 168 ZHEN-XING ROAD LIUJIAGUAN TOWN TAICANG JIANGSU, 215433 CH 215433 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-09 |