FDA Adverse Event
Malfunction
Summary report: N
FREECURVE
MDR report key: 9513101
·
Received December 23, 2019
Report
- Report Number
- 3007802293-2019-00048
- Event Type
- Malfunction
- Date Received
- December 23, 2019
- Date of Event
- December 4, 2019
- Report Date
- December 23, 2019
- Manufacturer
- HANDICARE STAIRLIFTS B.V
- Product Code
- PCD
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SWIVEL MOTOR ACTUATOR SHAFT BROKEN, USER FELL DOWN THE STAIRS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1308616 | FREECURVE | STAIRLIFTS | PCD | HANDICARE STAIRLIFTS B.V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |