FDA Adverse Event
Other
Summary report: N
NA
MDR report key: 110229
·
Received July 9, 1997
Report
- Report Number
- 110229
- Event Type
- Other
- Date Received
- July 9, 1997
- Date of Event
- March 13, 1997
- Report Date
- April 16, 1997
- Manufacturer
- HARD MFG CO., INC.
- Product Code
- FNJ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE RESIDENT WAS BEING REPOSITIONED FOR PERSONAL CARE, TURNED ON HER SIDE. SHE WAS ACCUSTOMED TO HOLDING ON TO THE SIDERAIL FOR SUPPORT DURING THIS ACTIVITY. ON THIS DATE THE SIDERAIL WAS INEXPLICABLY LOWERED, CAUSING THE RESIDENT LOSS OF SUPPORT RESULTING IN HER FALL TO THE FLOOR FROM A HEIGHT OF APPROX. 30 INCHES AND CAUSING A FRACTURED LEFT HIP AND FRACTURED PELVIS. THE RESIDENT WAS EVALUATED AT A LOCAL HOSPITAL E.D. AND RETURNED TO THIS FACILITY FOR ON-GOING CARE. SHE HAD NO POTENTIAL FOR AMBULATION PRIOR TO THE EVENT; THEREFORE TREATMENT/REHAB IN THIS DIRECTION WAS NOT CONSIDERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | SIDE RAIL - BED; FULL LENGTH | FNJ | HARD MFG CO., INC. | 3089 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Other |