MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-04 for FREECURVE manufactured by Handicare Stairlifts B.v..
[104411132]
Outcome of investigation is pending. A final report will be submitted upon completion.
Patient Sequence No: 1, Text Type: N, H10
[104411133]
Customer reported stairlift has electrical sparks when used. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007802293-2018-00015 |
| MDR Report Key | 7397902 |
| Date Received | 2018-04-04 |
| Date of Report | 2018-04-04 |
| Date of Event | 2018-03-05 |
| Date Facility Aware | 2018-03-05 |
| Date Added to Maude | 2018-04-04 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 | FREECURVE |
| Product Code | PCD |
| Date Received | 2018-04-04 |
| 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 PO BOX 39 HEERHUGOWAARD NOORD, HOLLAND 1700AA NL 1700AA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-04 |