FDA Adverse Event
Malfunction
Summary report: N
HANDICARE
MDR report key: 10065631
·
Received May 18, 2020
Report
- Report Number
- 3007802293-2020-00009
- Event Type
- Malfunction
- Date Received
- May 18, 2020
- Report Date
- May 18, 2020
- Manufacturer
- HANDICARE STAIRLIFTS B.V
- Product Code
- PCD
- UDI-DI
- 08719326254326
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 1
WHEN THE USER WAS APPROXIMATELY HALF-WAY UP THE STAIRS, THE SEATBELT BROKE AND THE USER FELL FROM THE SEAT. THE USER'S FATHER CAUGHT HIM, RETURNED HIM TO THE SEAT, AND CONTINUED THE RIDE TO THE TOP OF THE STAIRS. THE USER WAS NOT INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 529361 | HANDICARE | 1100 | PCD | HANDICARE STAIRLIFTS B.V | 1100 | 08719326254326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |