MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-19 for 2000 OUTDOOR manufactured by Handicare.
[106625376]
Outcome of investigation is pending. A final report will be submitted upon completion.
Patient Sequence No: 1, Text Type: N, H10
[106625377]
An end user was sitting in the chair seat of a 2000 outdoor stairlift and while in motion, the chair seat broke away from the rail. The end user tumbled down the stairway. Following the fall he had a gash on his head, hurt his arm, and his legs. He went to an urgent care facility for attention. He was treated for his injuries and was home the same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011268530-2018-00016 |
| MDR Report Key | 7443160 |
| Date Received | 2018-04-19 |
| Date of Report | 2018-04-19 |
| Date of Event | 2018-03-21 |
| Date Mfgr Received | 2018-03-21 |
| Date Added to Maude | 2018-04-19 |
| 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 | 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 OUTDOOR |
| Generic Name | OUTDOOR STAIRLIFT |
| Product Code | PCD |
| Date Received | 2018-04-19 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE |
| Manufacturer Address | 82 FIRST AVENUE PENSNETT ESTATE KINGSWINFORD, DY6 7FJ UK DY6 7FJ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-04-19 |