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.
[125917089]
Retrospective medical device reporting.
Patient Sequence No: 1, Text Type: N, H10
[125917090]
When tap to floor was used by the customer on the freecurve in combination with a hinge rail, it occurred that the freecurve unit did not stop at the hinge rail. The customer was most likely not wearing a seat belt, customer said she fell forward a bit, more of a jerk and bruised her arm. Policy would be that tap to floor option is "manually" switched off in the software of the powerpack configurator if a hinge rail configuration is used: however, it appears that this was not always done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007802293-2018-00042 |
| MDR Report Key | 8030467 |
| Date Received | 2018-11-01 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-06-05 |
| 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 | 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 | 3 |
| Brand Name | FREECURVE |
| Generic Name | STAIRLIFTS |
| Product Code | PCD |
| Date Received | 2018-11-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | 2 YR |
| 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 |