MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-05-10 for 2000 OCP manufactured by Handicare.
[145656871]
The user fell out of the seat of the stairlift while travelling up the stairs. The lift didn't stop at the top of the stair case as it should, driving through the mechanical end-stop. The trunnion subsequently ran off the rail end causing the seat to tilt forward and the user to fall out of the seat. The user was not wearing the seatbelt and sustained bruising in the fall. The user did not sustain serious injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011268530-2019-00018 |
| MDR Report Key | 8601566 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-08 |
| Date of Event | 2019-04-12 |
| Date Facility Aware | 2019-04-12 |
| Date Mfgr Received | 2019-04-01 |
| Date Added to Maude | 2019-05-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ANDREW WILLIAMS |
| Manufacturer Street | 82 FIRST AVENUE PENSNETT ESTATE |
| Manufacturer City | KINGSWINFORD, WEST MIDLANDS DY6 7FJ |
| Manufacturer Country | UK |
| Manufacturer Postal | DY6 7FJ |
| Manufacturer G1 | HANDICARE |
| Manufacturer Street | 82 FIRST AVENUE PENSNETT ESTATE |
| Manufacturer City | KINGSWINFORD, WEST MIDLANDS DY6 7FJ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | DY6 7FJ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2000 |
| Generic Name | STAIRLIFT |
| Product Code | PCD |
| Date Received | 2019-05-10 |
| Model Number | 2000 |
| Catalog Number | OCP |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE |
| Manufacturer Address | 82 FIRST AVENUE PENSNETT ESTATE KINGSWINFORD, WEST MIDLANDS DY6 7FJ UK DY6 7FJ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-10 |