FDA Adverse Event
Malfunction
Summary report: N
HANDICARE
MDR report key: 23854002
·
Received December 19, 2025
Report
- Report Number
- 3013423626-2025-00006
- Event Type
- Malfunction
- Date Received
- December 19, 2025
- Date of Event
- November 17, 2025
- Report Date
- December 17, 2025
- Manufacturer
- HANDICARE STAIRLIFTS BV
- Product Code
- PCD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
DEVICE RETURNED TO AND ANALYSED BY INITIAL DISTRIBUTOR HANDICARE UK. INCORRECT ASSEMBLY BY INSTALLING DEALER CAUSING DAMAGE TO UNIT AND ULTIMATE FAILURE, ERROR REVIEWED WITH DEALER.
Description of Event or Problem · 0
THE END USER COMPLETED TRAVEL ON THE STAIRLIFT AND SUCCESSFULLY TRANSFERRED FROM THE LIFT. THE END USER REPORTED THAT AFTER GETTING OFF OF THE LIFT SOMETHING SNAPPED AND THE LIFT TURNED OVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2313058 | HANDICARE | STAIRLIFT | PCD | HANDICARE STAIRLIFTS BV | 1100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |