FDA Adverse Event
Malfunction
Summary report: N
EZ WAY
MDR report key: 316134
·
Received February 13, 2001
Report
- Report Number
- MW1021075
- Event Type
- Malfunction
- Date Received
- February 13, 2001
- Date of Event
- February 1, 2001
- Report Date
- February 5, 2001
- Manufacturer
- EZ WAY INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHILE STAFF WAS TRANSFERRING RESIDENT USING STAND LIFT, PLASTIC CLIP BELT ON EZ STAND HARNESS BROKE AND RESIDENT FELL TO THE FLOOR. RESIDENT WAS CLOSELY MONITORED, BUT SUSTAINED NO INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5512 | EZ WAY | EZ STAND HARNESS | FSA | EZ WAY INC. | 50-910 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other |