MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-03-18 for BRUNO ELECTRA RIDE ELITE SRE-2000 manufactured by Bruno Independent Living Aids.
[3256265]
The customer/end user was riding the stairlift down the stairs in his home when the stairlift pulled away from the foundation it was mounted to. Because of this the customer was thrown to the floor causing injury to him.
Patient Sequence No: 1, Text Type: D, B5
[10637892]
Due to pending investigation, no additional information is available at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2131358-2013-00018 |
| MDR Report Key | 3020633 |
| Report Source | 99 |
| Date Received | 2013-03-18 |
| Date of Report | 2013-03-13 |
| Date of Event | 2013-01-31 |
| Date Mfgr Received | 2013-01-31 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2013-03-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRY ANDRUS |
| Manufacturer Street | 1780 EXECUTIVE DR. PO BOX 84 |
| Manufacturer City | OCONOMOWOC WI 53066 |
| Manufacturer Country | US |
| Manufacturer Postal | 53066 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRUNO ELECTRA RIDE ELITE |
| Generic Name | INCLINED STAIRWAY ELEVATOR |
| Product Code | ILK |
| Date Received | 2013-03-18 |
| Model Number | SRE-2000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-03-18 |