FDA Adverse Event
Injury
Summary report: N
EZ LIFT
MDR report key: 1224534
·
Received November 7, 2008
Report
- Report Number
- 2183887-2008-00003
- Event Type
- Injury
- Date Received
- November 7, 2008
- Date of Event
- September 6, 2008
- Report Date
- November 7, 2008
- Manufacturer
- EZ WAY, INC.
- Product Code
- FNG
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EZ WAY REPRESENTATIVE PERFORMED EXTENSIVE INSERVICING WITH FACILITY STAFF, PROVIDED ADDITIONAL TRAINING MATERIALS, AND STRESSED THE IMPORTANCE OF PROPER SLING APPLICATION.
Description of Event or Problem · 1
A RESIDENT WAS BEING TRANSFERRED FROM A BED TO A WHEELCHAIR IN AN EZ LIFT, AND SLID OUT OF THE SLING ONTO THEIR KNEES, BREAKING BOTH FEMURS. THE SLING WAS NOT HOOKED TO THE LIFE APPROPRIATELY. THE FACILITY ACKNOWLEDGED THAT THE SLING WAS POSITIONED INCORRECTLY ON THE RESIDENT. EZ WAY WAS NOTIFIED ON 10/08/2008 OF THE INCIDENT, AND SCHEDULED A VISIT TO THE FACILITY TO INVESTIGATE AND TRAIN FACILITY STAFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EZ LIFT | PATIENT LIFT | FNG | EZ WAY, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |