FDA Adverse Event
Other
Summary report: N
SIDE RAILS
MDR report key: 263357
·
Received February 11, 2000
Report
- Report Number
- 2182305-2000-00003
- Event Type
- Other
- Date Received
- February 11, 2000
- Date of Event
- January 3, 2000
- Report Date
- January 18, 2000
- Manufacturer
- SUNRISE MEDICAL CCG
- Product Code
- FNJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RESIDENT FELL ON AN OLD STYLE BED RAIL BRACKET WHICH PUNCTURED THE SKIN UNDER THE RIGHT ARM AND EXITED, LEAVING THE SIDE PIERCED. RESIDENT TRANSFERRED TO HOSPITAL. RESIDENT WAS RETURNING TO BED FROM THE BATHROOM AND FORGOT TO USE THE WALKER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIDE RAILS | SAFETY SIDE RAILS | FNJ | SUNRISE MEDICAL CCG | F190 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization |