MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-02 for DRIVE 16500BV manufactured by Fort Metal Plastic Co., Ltd..
[90929129]
(b)(4) is the initial importer of the device in question. We received an email notification of the death of a patient from a nursing home. There seems to be inconsistency in the report from the facility. One person said that patient slid down off the side of the bed and her head got stuck at the end of the rail, while another suggested that the patient became stuck in between the bars of the rail. At this time, we do not know the type of bed to which the rail was paired, and how it was installed prior to the incident. This report is based on the information that was provided by the customer and attorney.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00033 |
| MDR Report Key | 6998128 |
| Date Received | 2017-11-02 |
| Date of Report | 2017-03-07 |
| Date of Event | 2017-03-07 |
| Date Facility Aware | 2017-03-07 |
| Report Date | 2017-04-04 |
| Date Reported to Mfgr | 2017-04-04 |
| Date Added to Maude | 2017-11-02 |
| 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 | FNJ |
| Date Received | 2017-11-02 |
| Model Number | 16500BV |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FORT METAL PLASTIC CO., LTD. |
| Manufacturer Address | YI HE CIVIL AFFAIRS INDUSTRIAL GUONGDONG GUANGDONG, 516023 CH 516023 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-11-02 |