MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-26 for DRIVE 12203KD-1 manufactured by Ningbo Shenyu Medical Equipment Co., Ltd.9.
| Report Number | 2438477-2019-00047 |
| MDR Report Key | 8830414 |
| Date Received | 2019-07-26 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-03-03 |
| Date Facility Aware | 2019-05-31 |
| Report Date | 2019-07-26 |
| Date Reported to FDA | 2019-07-26 |
| Date Reported to Mfgr | 2019-07-26 |
| Date Added to Maude | 2019-07-26 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE |
| Generic Name | SHOWER CHAIR |
| Product Code | ILS |
| Date Received | 2019-07-26 |
| Model Number | 12203KD-1 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.9 |
| Manufacturer Address | WEST OF TANJIALING ROAD YUYAO ZHEJIANG 315408 CH 315408 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-26 |