MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-26 for 2000 CURVED STAIRLIFT manufactured by Handicare.
[107207727]
Outcome of investiagation is pending. A final report will be submitted upon completion.
Patient Sequence No: 1, Text Type: N, H10
[107207728]
End use had their swivel release lever come unlocked while riding the unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007802293-2018-00019 |
| MDR Report Key | 7466501 |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-03-20 |
| Date Mfgr Received | 2018-03-27 |
| Date Added to Maude | 2018-04-26 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | REKHA JANARTHANAN |
| Manufacturer Street | 10888 METRO COURT |
| Manufacturer City | MARYLAND HEIGHTS MO 63043 |
| Manufacturer Country | US |
| Manufacturer Postal | 63043 |
| Manufacturer Phone | 3142198682 |
| Manufacturer G1 | HANDICARE |
| Manufacturer Street | 82 FIRST AVENUE PENSNETT ESTATE |
| Manufacturer City | KINGSWINFORD, DY67FJ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | DY67FJ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 2000 CURVED STAIRLIFT |
| Generic Name | 2000 CURVED STAIRLFIT |
| Product Code | PCD |
| Date Received | 2018-04-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE |
| Manufacturer Address | 82 FIRST AVENUE PENSNETT ESTATE KINGSWINFORD, DY67FJ UK DY67FJ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-26 |