FDA Adverse Event
Malfunction
Summary report: N
THILL INC
MDR report key: 115165
·
Received August 21, 1997
Report
- Report Number
- 115165
- Event Type
- Malfunction
- Date Received
- August 21, 1997
- Date of Event
- August 17, 1997
- Report Date
- August 20, 1997
- Manufacturer
- THILL INC
- Product Code
- FNJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RESIDENT ROLLED INTO BED SIDE RAILS, CAUSING THE SIDE RAILS TO BREAK LOOSE. RESIDENT FELL TO FLOOR TWO LACERATIONS TO RT SIDE OF FACE. SENT TO THE HOSPITAL FOR SUTURES. THE ORIGINAL WELDING BROKE LOOSE FROM THE SIDE RAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THILL INC | BED SIDE RAIL | FNJ | THILL INC | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 94 YR | Other |