FDA Adverse Event
Death
Summary report: N
EZ LIFT/NORAM SLING
MDR report key: 1416083
·
Received July 15, 2009
Report
- Report Number
- 2183887-2009-00001
- Event Type
- Death
- Date Received
- July 15, 2009
- Date of Event
- June 20, 2009
- Report Date
- July 15, 2009
- Manufacturer
- EZ WAY, INC.
- Product Code
- FNG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EZ WAY CONTACTED THE FACILITY AND WAS TOLD THE INCIDENT WAS NOT CAUSED BY ANY MALFUNCTION OF THE LIFT, BUT WAS CAUSED BY USER ERROR. AN EZ WAY SLING WAS NOT USED IN THE TRANSFER.
Description of Event or Problem · 1
DURING A TRANSFER WITH AN EZ LIFT AND A NORAM SLING, A RESIDENT FELL BACK OUT OF THE SLING, HITTING HIS HEAD ON THE FLOOR. THE RESIDENT WAS TAKEN TO THE HOSPITAL AND LATER EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EZ LIFT/NORAM SLING | LIFT/SLING | FNG | EZ WAY, INC. | 798-LIFT 100-SLING | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Death| H |