MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-04 for DRIVE 15201BV manufactured by Hangzhou Fuyang Hongwei Metal.
[71684046]
(b)(4) received notification of an incident regarding a half rail that (b)(4) imports and distributes. The patient was attempting to lean on the half rail to get out of bed, when allegedly the welding of the half rail broke leading her to fall and bruise her arms. The provider is holding onto the half rail therefore, drive is not able to evaluate and confirm the defect. This information has been provided by providence health & services.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00032 |
| MDR Report Key | 6457069 |
| Date Received | 2017-04-04 |
| Date of Report | 2017-03-07 |
| Date of Event | 2017-03-06 |
| Date Facility Aware | 2017-03-07 |
| Report Date | 2017-04-04 |
| Date Reported to FDA | 2017-04-04 |
| Date Reported to Mfgr | 2017-04-04 |
| Date Added to Maude | 2017-04-04 |
| 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 | BED RAIL |
| Product Code | IKX |
| Date Received | 2017-04-04 |
| Model Number | 15201BV |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANGZHOU FUYANG HONGWEI METAL |
| Manufacturer Address | LIAOAN VILLAGE WANSHI TOWN FUYANG DISTRICT, HANGZHOU CITY ZHEJIANG 311406 CH 311406 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-04 |