MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-01 for FREECURVE manufactured by Handicare Stairlifts B.v.
[125916976]
Retrospective medical device reporting.
Patient Sequence No: 1, Text Type: N, H10
[125916977]
Mrs (b)(6) was on the stairlift, coming down the stairs when the stairlift jolted (after inspection, 5 teeth had snapped off rail and customer fell off the lift. Customer was not wearing the seatbelt as she says it is too small for her. Bruising to side and legs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007802293-2018-00043 |
| MDR Report Key | 8030532 |
| Date Received | 2018-11-01 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-12-06 |
| Date Facility Aware | 2018-10-30 |
| Date Added to Maude | 2018-11-01 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FREECURVE |
| Generic Name | STAIRLIFTS |
| Product Code | PCD |
| Date Received | 2018-11-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE STAIRLIFTS B.V |
| Manufacturer Address | NEWTONSTRAAT 35 P.O. BOX 39 HEERHUGOWAARD, 1700AA NL 1700 AA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-01 |