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 2019-02-05 for HANDICARE STAIRLIFTS 2000 INTERNAL CURVE manufactured by Handicare Accessibility Uk Ltd.
[134999084]
Retrospective mdr reporting.
Patient Sequence No: 1, Text Type: N, H10
[134999205]
Mechanical end stop weld broke of the rail and the pack came off the rail. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011268530-2019-00005 |
| MDR Report Key | 8304644 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-05 |
| Date of Event | 2018-07-01 |
| Date Facility Aware | 2019-02-05 |
| Date Added to Maude | 2019-02-05 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ANDREW WILLIAMS |
| Manufacturer Street | 82 FIRST AVENUE PENSNETT ESTATE |
| Manufacturer City | KINGSWINFORD DUDLEY, WEST MIDLANDS DY6 7FJ |
| Manufacturer Country | UK |
| Manufacturer Postal | DY6 7FJ |
| Manufacturer G1 | HANDICARE ACCESSIBILITY UK LTD |
| Manufacturer Street | 82 FIRST AVENUE PENSNETT ESTATE |
| Manufacturer City | KINGSWINFORD DUDLEY, 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 | HANDICARE STAIRLIFTS 2000 |
| Generic Name | STAIRLIFTS |
| Product Code | PCD |
| Date Received | 2019-02-05 |
| Model Number | INTERNAL CURVE |
| Device Availability | * |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE ACCESSIBILITY UK LTD |
| Manufacturer Address | 82 FIRST AVENUE PENSNETT ESTATE KINGSWINFORD DUDLEY, WEST MIDLANDS DY6 7FJ UK DY6 7FJ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-05 |