MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-20 for ROSCOE MEDICAL manufactured by .
[100508564]
The end-user was at her home and attempted to ambulate from her bed to the commode when a bed rail attached to her bed came apart or otherwise malfunctioned, causing her to fall. The end-user sustained an oblique fracture through the distal diaphysis of the right fibula, an equinus deformity of the foot, and complications resulting from internal implantation of an orthopedic device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2018-00006 |
| MDR Report Key | 7283562 |
| Date Received | 2018-02-20 |
| Date of Report | 2018-02-20 |
| Date of Event | 2014-09-05 |
| Date Facility Aware | 2016-06-04 |
| Report Date | 2018-02-20 |
| Date Reported to FDA | 2018-02-20 |
| Date Added to Maude | 2018-02-20 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | ROSCOE MEDICAL |
| Generic Name | DELUXE POWDER COATED BED RAIL |
| Product Code | FPS |
| Date Received | 2018-02-20 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2018-02-20 |