MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-07-22 for BRUNO ELECTRA-RIDE II SRE-1550 manufactured by Bruno Independent Living Aids.
[16124438]
The customer was riding the stairlift up the stairs, when it suddenly tipped 90 degrees and allegedly dumped her down the stairs. She fell down the stairs.
Patient Sequence No: 1, Text Type: D, B5
[16241574]
At the time of the submission of this report, the unit in question is off limits to any further investigation due to possible litigation. No further details are available at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2131358-2008-00014 |
| MDR Report Key | 2853205 |
| Report Source | 08 |
| Date Received | 2008-07-22 |
| Date of Report | 2008-06-23 |
| Date of Event | 2008-06-23 |
| Date Mfgr Received | 2008-06-23 |
| Device Manufacturer Date | 2004-03-01 |
| Date Added to Maude | 2012-12-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRY ANDRUS |
| Manufacturer Street | 1780 EXECUTIVE DRIVE 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-RIDE II |
| Generic Name | INCLINED STAIRWAY ELEVATOR |
| Product Code | ILK |
| Date Received | 2008-07-22 |
| Model Number | SRE-1550 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2008-07-22 |