FDA Adverse Event
Injury
Summary report: N
EZ WAY
MDR report key: 10157767
·
Received June 15, 2020
Report
- Report Number
- MW5095001
- Event Type
- Injury
- Date Received
- June 15, 2020
- Date of Event
- May 6, 2020
- Report Date
- June 11, 2020
- Manufacturer
- EZ WAY, INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SD, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 1
AN EMPLOYEE WAS TRANSFERRING A RESIDENT USING AN EZ WAY SIT TO STAND PATIENT LIFT. WHILE TRANSFERRING THE ACTUATOR ON THE LIFT BROKE CAUSING THE RESIDENT TO FALL TO FLOOR WHERE HE SUSTAINED A NECK FRACTURE. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 616645 | EZ WAY | LIFT, PATIENT, NON-AC-POWERED | FSA | EZ WAY, INC. | 898 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Hospitalization |