MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for PROBASICS BSFC manufactured by Ningbo South Industrial Co., Ltd.
[187260374]
Patient got her leg tangled up in leg of commode causing her to fall sustaining a fracture of her pelvis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2020-00001 |
| MDR Report Key | 9552795 |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-11-22 |
| Date Facility Aware | 2019-12-11 |
| Report Date | 2020-01-06 |
| Date Reported to FDA | 2020-01-06 |
| Date Reported to Mfgr | 2020-01-06 |
| Date Added to Maude | 2020-01-06 |
| 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 | PROBASICS |
| Generic Name | FOLDING 3-IN-1 COMMODE |
| Product Code | ILS |
| Date Received | 2020-01-06 |
| Model Number | BSFC |
| 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, CHINA 315171 CH 315171 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-06 |