MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2001-12-04 for BRUNO ELECTRA-RIDE III CRE-2100 * manufactured by Bruno Independent Living Aids.
[220730]
The customer was attempting to get off the seat of the stairlift at the top of the seat the wrong way. When pt exited the chair, pt was over the step instead of the landing and fell.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2131358-2001-00003 |
| MDR Report Key | 365246 |
| Report Source | 04 |
| Date Received | 2001-12-04 |
| Date of Report | 2001-12-03 |
| Date of Event | 2001-01-31 |
| Date Mfgr Received | 2001-07-05 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2001-12-13 |
| 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 | 0 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | TERRY ANDRUS |
| Manufacturer Street | 1780 EXECUTIVE DRIVE PO BOX 84 |
| Manufacturer City | OCONOMOWOC WI 53066 |
| Manufacturer Country | US |
| Manufacturer Postal | 53066 |
| Manufacturer Phone | 2625674990 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRUNO ELECTRA-RIDE III |
| Generic Name | INCLINED STAIRWAY ELEVATOR |
| Product Code | ILK |
| Date Received | 2001-12-04 |
| Model Number | CRE-2100 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 354362 |
| Manufacturer | BRUNO INDEPENDENT LIVING AIDS |
| Manufacturer Address | 1780 EXECUTIVE DRIVE PO BOX 84 OCONOMOWOC WI 53066 US |
| Baseline Brand Name | BRUNO ELECTRA-RIDE III |
| Baseline Generic Name | INCLINED STAIRWAY ELEVATOR |
| Baseline Model No | CRE-2100 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2001-12-04 |