MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-30 for CAREX FGB65100 0000 B651-00 manufactured by Ningbo South Industrial Co., Ltd..
| Report Number | 3012316249-2019-00017 |
| MDR Report Key | 8840860 |
| Date Received | 2019-07-30 |
| Date of Report | 2019-07-30 |
| Date of Event | 2019-03-15 |
| Date Facility Aware | 2019-07-09 |
| Report Date | 2019-07-30 |
| Date Reported to FDA | 2019-07-30 |
| Date Reported to Mfgr | 2019-07-30 |
| Date Added to Maude | 2019-07-30 |
| 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 | CAREX |
| Generic Name | ADJUSTABLE BATH & SHOWER SEAT WITH BACK |
| Product Code | ILS |
| Date Received | 2019-07-30 |
| Model Number | FGB65100 0000 |
| Catalog Number | B651-00 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NINGBO SOUTH INDUSTRIAL CO., LTD. |
| Manufacturer Address | FENGCHENG VILLAGE, JISHIGANG T YINZHOU NINGBO ZHEJIANG, 315171 CH 315171 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-30 |