FDA Adverse Event
Summary report: N
*
MDR report key: 344032
·
Received July 9, 2001
Report
- Report Number
- 344032
- Date Received
- July 9, 2001
- Date of Event
- December 14, 2000
- Report Date
- June 25, 2001
- Manufacturer
- SMITH & DAVIS MFG CO, AMEDCO CO
- Product Code
- FNL
- Report Source
- User Facility report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE STATE DEPT OF HEALTH WHILE INVESTIGATING A COMPLAINT ON A DEATH IN THE FACILITY HAS STATED THEY FEEL THAT SIDE RAILS CONTRIBUTED TO THE DEATH OF THE RESIDENT. THE FACILITY CONDUCTED AN INVESTIGATION ON THE INCIDENT AND DID NOT FIND THIS TO BE THE CASE. THE CHARGE NURSE IN CHARGE AT THE TIME OF THE INCIDENT STATED THAT THE RESIDENT WAS FOUND ON RIGHT SIDE WITH FACE INTO BED RAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30752 | * | 1/2 SIDE RAILS | FNL | SMITH & DAVIS MFG CO, AMEDCO CO | DATE OF MFG: 06/89 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR |