MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-06-30 for * SRE 1550 ELECTRA RIDE II manufactured by Bruno Independent Living Aids, Inc..
[17488544]
Details of incident are unknown at the time of this report. The customer was injured while riding their stairway elevator when it malfunctioned, according to attorney's letter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2131358-2003-00007 |
| MDR Report Key | 469926 |
| Report Source | 00 |
| Date Received | 2003-06-30 |
| Date of Report | 2003-06-30 |
| Date of Event | 2003-04-18 |
| Date Mfgr Received | 2003-05-30 |
| Device Manufacturer Date | 2002-06-01 |
| Date Added to Maude | 2003-07-09 |
| 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 INDUSTRIAL 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 | * |
| Generic Name | INCLINED STAIRWAY ELEVATOR |
| Product Code | ILK |
| Date Received | 2003-06-30 |
| Model Number | SRE 1550 ELECTRA RIDE II |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 458771 |
| Manufacturer | BRUNO INDEPENDENT LIVING AIDS, INC. |
| Manufacturer Address | 1780 EXECUTIVE DR. PO BOX 84 OCONOMOWOC WI 53066 US |
| Baseline Brand Name | * |
| Baseline Generic Name | INCLINED STAIRWAY ELEVATOR |
| Baseline Model No | SRE 1550 ELECTR |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2003-06-30 |