FDA Adverse Event
Injury
Summary report: N
DFS HOME CARE- ADVANCED DYNAMIC FLOTATION SYSTEM
MDR report key: 144836
·
Received January 16, 1998
Report
- Report Number
- 144836
- Event Type
- Injury
- Date Received
- January 16, 1998
- Date of Event
- January 7, 1998
- Report Date
- January 16, 1998
- Manufacturer
- HUNTLEIGH HEALTHCARE INC
- Product Code
- FNM
- Report Source
- User Facility report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
CNA REPORTED THAT RESIDENT FELL OUT OF BED. FLOTATION MATTRESS OVER REGULAR MATTRESS & SIDERAIL DISENGAGED. SUSTAINED COMMINUTED FRACTURES OF THE DISTAL RIGHT TIBIA & FIBULA +2 SKIN TEARS RIGHT ARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DFS HOME CARE- ADVANCED DYNAMIC FLOTATION SYSTEM | FLOTATION MATTRESS | FNM | HUNTLEIGH HEALTHCARE INC | DFSH 2000 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |