MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-02-12 for BRUNO ELECTRA-RICE II SRE-1550 manufactured by Bruno Independent Living Aids.
[2141393]
Patient sustained serious injuries when the arm of her electra-ride ii straight-rail stairlift broke away as she was being carried up the stairs at her residence, causing her to fall down the stairs.
Patient Sequence No: 1, Text Type: D, B5
[9207122]
As of the date of this submission, no evaluation has been done due to possible litigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2131358-2007-00011 |
| MDR Report Key | 2171401 |
| Report Source | 04 |
| Date Received | 2007-02-12 |
| Date of Report | 2007-01-11 |
| Date of Event | 2006-12-11 |
| Date Mfgr Received | 2007-01-11 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2011-07-26 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRY ANDRUS |
| Manufacturer Street | 1780 EXECUTIVE DR. P.O. BOX 84 |
| Manufacturer City | OCONOMOWOC WI 53066 |
| Manufacturer Country | US |
| Manufacturer Postal | 53066 |
| Manufacturer Phone | 2625674990 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRUNO ELECTRA-RICE II |
| Generic Name | INCLINED STAIRWAY ELEVATOR |
| Product Code | ILK |
| Date Received | 2007-02-12 |
| Model Number | SRE-1550 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRUNO INDEPENDENT LIVING AIDS |
| Manufacturer Address | OCONOMOWOC WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-02-12 |