MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-27 for DRIVE 12486 manufactured by Ningbo Shenyu.
[140117811]
(b)(4) is the initial importer of the device which is a bath bench. The device was in use by the end-user for a year. Pms does not anticipate return of the device for evaluation. Patient requires compensation. The end-user was sitting on chair in his shower and the chair collapsed. The bracket connecting the seat to the legs had failed. His neck and back hit the wall. He injured his tailbone. Physical therapy and a chiropractor was required. He noted that the device was stored in a dry area of the bathroom.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2019-00012 |
| MDR Report Key | 8458364 |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-02-13 |
| Date Facility Aware | 2019-03-11 |
| Report Date | 2019-03-27 |
| Date Reported to FDA | 2019-03-27 |
| Date Reported to Mfgr | 2019-03-29 |
| Date Added to Maude | 2019-03-27 |
| 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 | DRIVE |
| Generic Name | BATH BENCH |
| Product Code | ILS |
| Date Received | 2019-03-27 |
| Model Number | 12486 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 13 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NINGBO SHENYU |
| Manufacturer Address | WEST OF TANJIALING ROAD JUYAO ZHEJIANG,, 315408 CH 315408 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-27 |