FDA Adverse Event
Summary report: N
*
MDR report key: 344028
·
Received July 9, 2001
Report
- Report Number
- 344028
- Date Received
- July 9, 2001
- Date of Event
- February 17, 2001
- 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 HAD 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 INVESTIGATION'S FINDINGS WERE A MEDICAL EVENT OCCURRED AND WAS OR WENT TO SIDE IN SLEEP WHEN THE MEDICAL EVENT OCCURRED PT FELL FORWARD, AS A RESULT OF THE MEDICAL EVENT, INTO THE SIDE RAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31043 | * | 1/2 SIDE RAILS | FNL | SMITH & DAVIS MFG CO, AMEDCO CO | DATE OF MTG: 06/89 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 97 YR |